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Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Position SummaryWe are currently searching for a candidate who can drive project management, strategic planning, and excellence within the WW Medical Cardiovascular &amp; Immunology (WWM CV&amp;I) organization. In addition, the candidate will drive the execution of the Early Asset/Indication Medical Strategy team (AIMS). Early AIMS drives the medical strategy and execution for a specific asset and/or disease area (indication), ensuring its deliverables address critical unmet needs of patients and healthcare systems worldwide.We are seeking a highly organized and detail-oriented professional to join our team. The AD MPM will work with the WWM CV&amp;I Lead(s) to manage AIMS operational excellence. The AD MPM plays an important role in organizing, managing, and communicating the core deliverables aligned to the Early AIMS goals and objectives for specific assets/indications in scope. In this role, the candidate will be responsible for handling complex multi-indication projects, where they will need to prioritize tasks effectively. The candidate must excel in balancing competing priorities and deadlines, ensuring that all projects move forward smoothly and are completed on time, to plan and within budget. This person plays a crucial role in ensuring efficient operations, strategic alignment, and effective knowledge exchange within the Medical team. Additionally, the role requires providing comprehensive support and project management for the organization, driving key projects to successful completion.The successful candidate will be a demonstrated leader with the breadth of professional experience and the drive to work with both internal and external partners to define and implement effective project management solutions. Key ResponsibilitiesAIMS – multi-indications.<ul><li>Lead planning and execution of the Early AIMS team operations, including effective meeting management, project management, and budget oversight for the TA area of responsibility.</li><li>Supervise and support working groups (where applicable) with deliverables and other requirements, to ensure they remain on track, meet deadlines, stay under budget and develop as planned.</li><li>Develops detailed project timelines ensuring cross-functional and third-party input is captured and projects are delivered on time and on budget.</li><li>Navigate the intricate dynamics of multiple assets and indications, ensuring projects are completed successfully and on time.</li><li>Oversees projects, ensuring compliance, alignment with the organization's strategic goals, and consistency across various initiatives.</li><li>Ensure organized and up-to-date records for easy access and retrieval. Store and maintain SharePoint (SP) sites and other relevant documentation.</li></ul>Other Regular Activities:<ul><li>S&amp;O and LT support (LT meetings, QBR, WWM Exchange/ Interchange, budget reduction scenario plans).</li><li>Support Department initiatives: Medical planning, Newsletter, Lunch and Learn, Dept meetings, Offsites.</li><li>Partner with finance PM including budget, forecasting, performance against targets, facilitate key budget discussions in partnership with the MPL.&nbsp;</li><li>Build relationships with key stakeholders, including Development Teams, Health Economics and Outcomes Research, Commercial and Medical team members, to influence strategic alignment on key Medical objectives.</li><li>Distribution List Management (adding / removing members, setting permissions)</li><li>Vendor Management, new vendor setup and onboarding on Ariba. Create and manage project briefs for external consultant engagement.</li><li>Coordination with the Congress Management team and EMCoE.</li><li>Adapt to flexible working conditions and support remote and in-office activities. Address ad hoc requests as they arise, ensuring prompt and effective resolutions.</li><li>Perform other regular activities to support team operations and objectives.</li></ul>The ideal candidate will embody BMS’s cultural pillars:<ul><li>Accountability: Demonstrates ownership and drives results with urgency.</li><li>Execution Excellence: Transforms strategy into action, delivering ambitious goals with precision.</li><li>Diverse Thinking: Leverages global perspectives to create innovative, patient-focused solutions.</li><li>Outcomes Mindset: Demonstrates a relentless focus on achieving impactful and measurable results for patients and the business.</li></ul> Qualifications &amp; Experience<ul><li>Bachelor’s degree in Life Sciences, Physical sciences or relevant discipline, advanced degrees preferred (MSc, PharmD, MBA)</li><li>Experience Requirements: 5+ years of experience in pharmaceutical research, development, medical affairs or commercialization. A solid foundation in science is indispensable.</li><li>Highly organized and motivated individual with the ability to work independently/effectively with cross functional teams.</li><li>This position requires a solid understanding of Medical Affairs organization</li><li>Experience in project/program management of complex projects involving cross-functional, multi-site, international teams.</li><li>Strong written and oral communication skills and demonstrated ability to interact directly and productively with team members and management and to manage and prioritize multiple competing priorities is also required.</li><li>Ability to engage in complex scientific discussions to develop /summarize clear follow-up/action plans and execute.</li><li>Strong experience with building relationships, leading strategic initiatives and programs, and collaborating across divisions with people of diverse business backgrounds and cultures.</li><li>Comfort with ambiguity, driving change and innovation across the team.</li><li>Travel: &lt;10% travel</li></ul>#LI-HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol Myers Squibb

Associate Director, WW Medical Affairs Project Manager, Cardiomyopathy

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.The Clinical Pharmacology and Pharmacometrics (CP&amp;P) team at BMS is responsible for the pharmacology and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. &nbsp;Composed of pharmacologists, pharmacometricians, data scientists and modelers, this group oversees the pharmacokinetic evaluation, pharmacometric exposure-response evaluation, quantitative systems pharmacology modeling, physiologically based pharmacokinetic modeling and model based meta-analysis of assets covering all therapeutic modalities, including small molecules, traditional and complex biologics and next gen cell therapies. All therapeutic areas are supported.The CP&amp;P team interacts with discovery and translational scientists, project leadership, early and late clinical development teams and commercial colleagues to provide input on clinical pharmacology profiling, dose optimization, formulation bridging, and combination strategies to enable faster and more effective drug development informed by core scientific principals and data.Responsibilities<ul><li>Independently contribute to compound development across various development phases</li><li>Represent Clin Pharm on asset teams and at governance meetings based on proficiency</li><li>Provide input to Phase 2/3 clinical study design and registrational strategy</li><li>Accountable for the Clinical Pharmacology Plan</li><li>Lead design of clinical pharmacology studies and manages data analysis, interpretation, and reporting</li><li>High proficiency in PK, PK/PD, and model informed drug development (MIDD) principles and analyses</li><li>Collaborate on cross-functional drug development teams, and regulatory submissions; serves as Clinical Pharmacology subject matter expert</li><li>Lead and participate in departmental initiatives and represent CP&amp;P on cross-functional initiatives / workstreams / taskforces</li><li>Participate in interactions with health authorities; serves as Clinical Pharmacology subject matter expert</li><li>Provide critical expertise to Business Development teams to assess external acquisitions</li></ul>Requirements<ul><li>Advanced Degree in related field (MS, Ph.D. or PharmD)</li><li>For Associate Director level with Ph.D. approximately 5+ years experience with demonstrated progression clinical pharmacology and Pharmacometrics experience</li><li>For Sr. Research Investigator, with Ph.D. approximately 2+ years experience with demonstrated progression clinical pharmacology and Pharmacometrics</li><li>Demonstrated ability to work in a dynamic team-oriented environment</li><li>Expertise in general drug development</li><li>Expertise in small molecule and/or biologic drug property characterization</li><li>Demonstrated stakeholder management with strong influence/leadership</li><li>Quantitative data analysis, POP PK/PD, and data visualization skills&nbsp;</li><li>Programming experience (e.g., NONMEN, Phoenix NLME, Monolix, R, WinNonlin, SAS, Splus etc.)</li></ul>#LI-HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Sr. Research Investigator/Associate Director, Clinical Pharmacology and Pharmacometrics

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.&nbsp;In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Bristol Myers Squibb is an integrated global biopharmaceutical company engaged primarily in the discovery, development, and commercialization of novel therapies in the areas of hematology/oncology, cardiovascular and inflammatory diseases through innovative small molecule, biologicals and cell therapy approaches.BMS R&amp;D is at a critical and exciting phase of development. As it expands and integrates its portfolio with recent and exciting new acquisitions, there is an opportunity for a science-driven, dynamic and ambitious individual to leading our Solid Tumor focused program management group under the Translational Development umbrella.Translational Development at BMSTranslational Development (TD) is part of the Global Research organization in BMS and leads mid- to late-stage clinical, pharmacological, and translational research and development activities for the BMS pipeline. The Translational Development team supports the late-stage portfolio for regulatory, translational development and life cycle management. This group integrates scientific learnings from the lab and clinic as well as business insights of multiple functions and leads the development of translational strategies at the franchise level.Summary&nbsp;Reporting to the Head of Program Management and Operations, Translational Development, the incumbent will be part of the late development translational group based in Summit, NJ and will be responsible for leading a team of program and project managers supporting the late development portfolio in the Solid Tumor pipeline. The ideal candidate will manage complex and high profile portfolio assets and facilitate broad, integrated plans to enable the delivery of our Translational development portfolio.Responsibilities:<ul><li>Managing complex and high-profile portfolio of assets, with broad visibility both within BMS and the external scientific community.</li><li>Execute processes to develop holistic Translational Development (TD) plans, manage issues and risk mitigations for the portfolio of assets. The scope includes: Biomarker delivery within clinical trials , Integrated Sciences delivery for key translational questions, Issue and risk mitigations for the portfolio of assets, Publications and presentations (internal and external), Regulatory responses and interactions</li><li>Establish meeting agendas to drive TD portfolio and documenting outcomes, decisions and key learnings to enhance collaboration and communication</li><li>Work closely with leaders and team to provide cross-functional TD overview</li><li>Responsible for the continuous evolution and measurement of processes and tools to drive efficiency and enhance business value.</li><li>Seeks opportunities to leverage and extend processes and tools to drive improved engagement and project oversight.&nbsp;</li><li>Mentors others within the team and in adjacent organizations to grow and develop broader stakeholder management and program management capabilities, including other TA program managers; as well as portfolio development program managers.</li><li>Creates visibility and maintains transparency into translational activities to key stakeholders that contributes to the overall translational plan for the asset</li><li>Independently manages preparation and coordination of collaboration meetings/engagements as needed; facilitating cross-functional and cross-industry engagement</li><li>Elaborates and ensures effective execution of a robust process for regular program and portfolio strategy reviews facilitated by Biomarker Operations staff; executes review processes for critical assets within his/her portfolio area in partnership with the TM Leader</li><li>Delivers business value and ensures effective use of resources by driving prioritization activities and raising visibility of areas for opportunistic action</li><li>Ensures appropriate compliance to contracting policies</li><li>Creates visibility into all proposed/contracted work and ensure review of milestones to support timely payment etc.</li></ul>Qualifications:<ul><li>B.S., M.S. (or Ph.D.) in a scientific discipline; PMP or equivalent experience is desirable</li><li>10+ years pharmaceutical industry experience in a variety of operational/scientific roles minimum 8+ years’ experience as a team leader in a highly matrixed environment</li><li>Shapes strategic approaches to scientific delivery, utilizing sophisticated negotiation and scenario planning</li><li>Works with a sense of urgency and experience managing multiple projects, building structure from ambiguity and helping teams to develop priorities</li></ul><ul><li>Experience designing and leading complex, global projects comprised of virtual team members of diverse styles, driving to successful outcomes with and without direct management responsibilities</li><li>Drives effective contract/fiscal management of project activities; experienced with the development of business cases for options based decision-making</li><li>Skilled listener with ability to manage complex internal – up, across, and down the hierarchy - and external relationships through constructive conflict management; experience with third party governance oversight desirable.</li><li>Negotiates an enterprise (vs. functional) perspective across BMS</li><li>Experienced in developing and implementing agile, creative solutions, utilizing direct and indirect resources, to solve business challenges within the line organization, across the company, and in partnership with external collaborators</li><li>Strong communicator experienced with influencing and interacting at all levels including with senior scientific, operational or external thought leaders to drive connectivity and efficiency of collaborative research</li></ul>Other Attributes<ul><li>Highly detail-oriented with excellent record keeping and organizational skills</li><li>Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic environment</li><li>Able to anticipate problems at project level</li><li>Proven track record of scientific approach to complex problem solving</li><li>Demonstrate in-depth, scientific-directed, innovative thinking</li><li>Recognizes interrelationships of facts/factors, processes, and systems</li><li>Recognize risk and propose contingency plans</li><li>Independently (or using collaborations) develop scientific direction for assignments&nbsp;</li><li>Recognize cross-functional issues</li><li>Communicates within the larger organization</li><li>Develops constructive relationships across organization to achieve the goals of the function and the business through leadership roles on cross-functional/divisional teams</li><li>Communicates within the larger organization and external community</li><li>Provides expert guidance to multi-disciplinary teams and senior management</li></ul>Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.&nbsp;#LI-HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Director, Translational Development Program Manager, Solid Tumor

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.The Director, Global Labeling Strategist, plays a critical role in overseeing the development of labeling content (TPL, CCDS, USPI, and EU SmPC) and strategies for early assets. From early development through regulatory approval, this role ensures the delivery of effective and competitive labeling documents that drive differentiation and compliance in global markets. Global Labeling Strategy &amp; Execution<ul><li>Lead development of Labeling strategy for new products by collaborating with cross-functional teams during clinical development, regulatory submission and launch.</li><li>Utilize insights from competitor analysis, labeling expertise and regulatory knowledge to author and develop competitive and optimal Target Product Labeling that aligns with market needs, company objectives and regulatory requirements.</li><li>Create and communicate initial labeling frameworks that meet with market needs and regulatory standards across global markets.</li><li>Drive internal alignment on labeling strategy and proactively identify and manage key risks.</li><li>Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities</li></ul>Operational oversight<ul><li>Conduct risk assessments to address labeling challenges and ensure labeling readiness.</li><li>Create labeling documents (TPL, CCDE, EUSPC, USPI), managing or overseeing initial negotiations with health authorities.</li><li>Ensure effective planning and execution of all cross-functional labeling activities to maximize speed and quality.</li></ul>Stakeholder Management<ul><li>Lead Labeling Strategy Team (LST).</li><li>Cultivate relationships with internal teams (Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical...) to ensure seamless labeling strategy execution</li><li>Coordinate labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality.</li></ul>Policy Influence &amp; Knowledge Sharing<ul><li>Identify opportunities to influence regulatory policy and climate with respect to labeling content, and process.</li><li>Mentor, coach, and develop team members to foster a high performing culture, as applicable.</li><li>Lead key initiatives (Process Improvements, procedural documents (e.g. Policies, SOPs, working instructions, job aids)</li><li>Innovation: &nbsp;Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.</li></ul>If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Director, Global Labeling Strategy, New Product Portfolio

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Position Responsibilities<ul><li>Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas</li><li>Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.&nbsp; </li><li>Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers. </li><li>Ensure consistent positions are presented in responses to global Health Authority (HA) queries. </li><li>Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plans. </li><li>Provide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA&nbsp;deadlines.</li><li>Contribute in the developing of target labeling. </li></ul>Degree / Experience Requirements<ul><li>Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience</li></ul>Key Competencies <ul><li>Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance. &nbsp;Experience utilizing leadership techniques to drive a team through the stages of team&nbsp;development.&nbsp;&nbsp;</li><li>Experience with developing regulatory strategies&nbsp;in coordination with clinical plans and marketing objectives.&nbsp;&nbsp;&nbsp;</li><li>Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor.</li><li>Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry.&nbsp;Experience coordinating communications within teams and across functions.&nbsp;&nbsp;</li><li>Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.</li><li>Ability to apply project management techniques within teams and effectively manage meetings. &nbsp;</li><li>Demonstrated ability to breakdown complex, scientific content into logical components.</li><li>Ability to coordinate global activities, facilitate issue resolution and conflict management.&nbsp;&nbsp;</li><li>Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks.&nbsp;&nbsp;&nbsp;</li><li>Demonstrated ability to negotiate with and influence others.</li><li>Understanding of strategic and tactical role for the drug development process. &nbsp;</li><li>Understanding of general global regulatory requirements for drugs in development.&nbsp;&nbsp;</li><li>Understanding of R&amp;D process and specific regulatory responsibilities/deliverables for the company decision points.</li></ul>For roles based in Washington, DC - The starting compensation for this job&nbsp;is a range from $156,000 - $195,000, plus incentive cash and stock opportunities (based on eligibility).The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided&nbsp;based on demonstrated&nbsp;experience.&nbsp;Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit Life at BMS.Benefit&nbsp;offerings&nbsp;are subject to the terms and conditions of the applicable plans then in effect&nbsp;and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support&nbsp;such as&nbsp;the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.&nbsp;Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.&nbsp;Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.#li-hybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)

<h4>What The Role Is</h4>Reporting to the Vice President, Construction, the Director, Construction is responsible for supervising various aspects of the overall construction function including construction management, planning and scheduling, project execution, and cost management. The primary objective is to review, execute, and approve construction projects in an efficient and cost-effective manner.If you don’t meet 100% of the below qualifications but see yourself contributing, please submit your resume.<h4>What You'll Be Doing</h4><ul><li>Connect with stakeholders to develop timelines and project deliverables.</li><li>Identify project pinch points in advance to avoid project delays where possible.</li><li>Coordinate expectations and deliverables with vendors and internal resources.</li><li>Secure internal resources as needed to keep the projects on schedule.</li><li>Develops project execution plans for 3rd party construction of projects for submittal and approval of executive management.</li><li>Connect with Design Team on long lead time materials and be familiar with alternatives/substitutes.</li><li>Participates in the review of plans and specifications for construction projects and expedite timely approvals from engineering</li><li>Confirm the accuracy of the scope of work, including any/all new work.</li><li>Accomplishes construction project results by defining project purpose and scope; establishing standards and protocols; scheduling and coordinating 3rd party contractors; evaluating milestone assumptions and conclusions; evaluating and implementing change orders.</li><li>Participate and provide weekly and monthly status reports to the Vice President of Construction.</li><li>Gives accurate project status reports with emphasis on projected completion cost. Ensures that all required administrative and field paperwork is completed timely, including review and approval of all invoices.</li><li>Attends weekly/monthly project meetings as well as pre-construction and post-construction meetings.</li><li>Inspect property under construction on a regular basis to ensure the work conforms to specifications, budget and schedule and initiates any repair or replacement needs and/or adjustment of working procedures. Regularly communicate with the project team and leadership regarding unit and property improvement status.</li><li>Keep stakeholders informed throughout all project stages to align on expectations and avoid surprises or misunderstandings, including to quickly inform appropriate stakeholders of expected delays, cost overruns or technical problems.</li><li>Ensures required construction records are maintained in a timely fashion.</li><li>Ensures records are timely filed in the project document management system.&nbsp;</li><li>Manages and reports construction budget for each project.</li><li>Manages 3rd party contractors, as assigned, by evaluating and monitoring performance.</li><li>Collaborate with business unit leaders and technical experts to develop accurate budgets.</li><li>Review and approve all invoices pertaining to construction; submits all approved bills per Clearway procedures and policies.</li><li>Assists with the preparation and analysis of performance status reports.</li><li>Tracks 3rd party contracts as required, including tracking change orders, credits, and material inventory.</li><li>Maintains budget updates by cost to complete reporting and reviews job progress for conformance with the project plan and schedule.</li><li>Interfacing with AHJ to determine requirements of a particular site.</li><li>Collaborate with Clearway Procurement to secure and screen vendors.</li><li>Assists Procurement with references and background information on the 3rd party contractors and suppliers.</li><li>Assist Procurement staff to ensure that all contract, permits and insurance requirements are in place prior to commencing work and maintained.</li><li>Ensures projects are completed in compliance with the agreed client contract, 3rd party contracts, purchase agreements, plans, and specifications and approved changes.</li><li>Perform other duties as assigned by management.</li><li>Schedule and complete assignments within required time-frames.</li><li>Ability to handle multiple tasks concurrently and to meet deadlines.</li><li>Ability to supervise direct reports, plan, manage, organize and communicate with team members.</li><li>Must be extremely organized and exhibit a high degree of attention to detail.</li><li>Maintain project timelines/calendars and make available as needed.</li><li>Deliver audience-specific communications that are accurate, clear, concise and professional.</li></ul><h4>What You'll Bring</h4><ul><li>Bachelor’s degree in construction management or related field from an accredited college or university required</li><li>10+ years of construction experience required</li><li>Ability to handle multiple concurrent efforts and provide high quality deliverables accurately and on time.</li><li>Experience in supervising and/or managing direct reports including hiring, annual reviews, delivering constructive feedback and directing work of others.</li><li>Demonstrated ability to communicate with all levels of internal and external customers.</li><li>Effective analytical and problem-solving skills.</li><li>Highly proficient with Microsoft Office applications including performing financial and analytical computations in Excel.</li><li>Detail oriented and adaptable to changing working requirements.</li><li>Ability to work well in a team-oriented, collaborative environment that emphasizes attention to detail, meeting deadlines and working together to achieve company-wide goals.</li></ul><h4>What Would Be Nice</h4><ul><li>Master’s degree in a related field a plus</li><li>Renewables experience preferred</li><li>Energy industry experience is a plus.</li></ul>Clearway will not sponsor nonimmigrant visas for this position (H-1B, TN, E-3, etc.).The pay rate for the successful candidate will depend on geographic location, skills, relevant and demonstrated experience, education, training and certifications, and other factors permitted by law. This role is eligible to earn an annual cash bonus, subject to personal and company performance goals.Salary Range Across all U.S. Locations$152,000—$228,000 USDClearway Energy Group is leading the transition to a world powered by clean energy. Along with our public affiliate Clearway Energy, Inc., our portfolio comprises approximately 11.6 GW of gross generating capacity in 26 states, including 9.1 GW of wind, solar, and battery energy storage assets, and over 2.5 GW of conventional dispatchable power generation providing critical grid reliability services. As we develop a nationwide pipeline of new energy projects for the future, Clearway’s operating fleet generates enough reliable electricity to power more than 3 million homes today. Clearway Energy Group is headquartered in San Francisco with offices in Denver, Houston, Phoenix, Princeton, and San Diego. For more information, visit clearwayenergygroup.com.Our Commitment to Diversity, Equity, &amp; Inclusion At Clearway, we create a community that isn’t about being the same – it’s about building a team of unique individuals, with different backgrounds &amp; skill sets, coming together to build something big &amp; make a difference in the world. Clearway’s team is dedicated to a clean energy future across a wide spectrum of roles &amp; responsibilities. Embodying our company values and operating principles, unique individuals come together over a common mission. We embrace opportunities to do challenging work that can change the world. We aspire to bring out the best in everyone. We share setbacks, celebrate successes, &amp; act with integrity &amp; accountability to get the job done. Working at Clearway, Hybrid Together Here at Clearway, we’re committed to balancing flexibility while fostering strong relationships with our teammates. We do this by prioritizing new hires based near one of our offices in San Francisco, San Diego, Scottsdale, Houston, Denver, &amp; Princeton. Our office-based employees typically work together from fabulous spaces on Tuesdays &amp; Thursdays to collaborate &amp; learn, build community, get to know one another, &amp; enjoy company-provided meals &amp; events. Clearway Energy is an equal opportunity employer that values a broad diversity of talent, knowledge, experience &amp; expertise. We intentionally foster a culture of inclusion that empowers our employees to deliver superior performance to the communities we serve. We encourage minorities, women, individuals with disabilities &amp; protected veterans to join the team. Clearway is a proud promoter of employment opportunities to our Military &amp; Veterans. What We Provide Clearway offers all eligible employees working 20+ hours per week a comprehensive menu of benefits: generous PTO, medical, dental &amp; vision care, HSAs with company contributions, health FSAs, dependent daycare FSAs, commuter benefits, relocation, &amp; a 401(k) plan with employer match, a variety of life &amp; accident insurances, fertility programs, adoption assistance, generous parental leave, tuition reimbursement, &amp; benefits for employees in same-sex marriages, civil unions &amp; domestic partnerships. For more on Clearway benefits, visit our Benefits Website.Notice to Applicants Clearway Energy is strongly committed to a philosophy of equal opportunity and fully complies with equal&nbsp;employment&nbsp;laws,&nbsp;ordinances and regulations for all applicants and employees. We will make reasonable accommodations to enable individuals with disabilities to apply and compete for employment opportunities for which they are qualified. If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to&nbsp;<a href="mailto:recruiting@clearwayenergy.com" target="_blank">recruiting@clearwayenergy.com</a>&nbsp;and let us know the nature of your request and your contact information.Notice to California Applicants Clearway Energy is strongly committed to a philosophy of equal opportunity and fully complies with&nbsp;equal&nbsp;employment&nbsp;laws,&nbsp;ordinances and regulations for all applicants and employees.

Clearway Energy Group

 Director, Construction

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Associate Director, Statistical Programming, provides functional expertise and leadership to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development and implementation of innovative strategies and technologies for clinical trial programming. Associate Director develop collaborative relationships and work effectively within Global Biometrics &amp; Data Sciences (GBDS), with external vendors and members of cross-functional development teams.Associate Director, Statistical Programming, independently leads improvement initiatives under sponsoring of Therapeutic Area Head or Statistical Programming leadership team. They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate decision making. Managers also lead the change management process (e.g. communication, training, stakeholder engagement).This position includes functional management responsibilities. In this role, Associate Director, Statistical Programming, is responsible for managing employees: set objectives, manage performance, and provide meaningful coaching and feedback. They also support the evaluation and recruitment of potential employees.Line manager of Statistical Programmers in addition to contractors and leased workers.Internal / External stakeholders, project team members, vendorsProject Responsibilities:<ul><li>Provides comprehensive programming leadership and support to &nbsp;complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices</li><li>Drives the development and implementation of innovative strategies and technologies for clinical trial programming</li><li>Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards</li><li>Leads the electronic submission preparation and review</li><li>Develops unambiguous and robust programming specifications (e.g. ADaM specifications)</li><li>Reviews planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities</li></ul>Improvement Responsibilities:<ul><li>Drives, Identifies, leads, and supports opportunities to enhance processes and technology</li><li>Communicates proactively and effectively around issues and risks and contributes to its remediation</li></ul>Managerial Responsibilities:<ul><li>Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains direct reports, resulting in an increasing level of capabilities within GBDS</li><li>Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager</li><li>Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements</li><li>Communicates with manager regarding promotions, performance concerns, and retention risks</li><li>Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results</li><li>Act as extended member of Statistical Programming Leadership Team in sharing and building up the line function vision</li></ul>Minimum Requirements:<ul><li>Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required</li></ul><ul><li>At least 10 years programming experience in industry including support of significant regulatory filings and minimum 5 years of experience in managing technical professionals in a regulated environment</li></ul><ul><li>For US positions: US military experience will be considered towards industry experience</li><li>Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data</li><li>&nbsp;Broad expertise in statistical programming and in developing computing strategies</li><li>In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases</li><li>Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21)</li><li>Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components)</li><li>Demonstrated ability to work in a team environment with clinical team members</li></ul>Preferred Requirements:<ul><li>Member of industry organizations or presented at Congresses/Conferences</li></ul>If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Associate Director Statistical Programming

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.&nbsp;In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Primary Responsibilities:<ul><li>Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate</li><li>Contributes to preparation of&nbsp; the development strategy that will allow for effective and safe utilization of the product</li><li>Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use.&nbsp; Develops trial designs that address study objectives that will support regulatory approval and market access.</li><li>Translates scientific questions into statistical terms and statistical concepts into layman terms</li><li>Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information</li><li>Ensures that all analyses conducted have clearly articulated hypotheses&nbsp; associated with them and that the trial design and data collected support conducting the analysis</li><li>Communicates effectively with clinical and regulatory partners and &nbsp;external opinion leaders</li><li>Builds the external reputation of BMS R&amp;D via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation</li><li>Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, &nbsp;clinical study reports, associated publications and other study level specification documents</li><li>Exercises cost-disciplined science in &nbsp;sizing of the trials and in the planning for the analyses to be conducted</li><li>Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables</li><li>Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information</li><li>Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents &nbsp;and scientific articles</li><li>Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.</li><li>Drives alignment at team (IPT) level, and escalates lack of team alignment to the GBS Lead for resolution</li><li>Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions</li><li>Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.</li><li>Keeps up-to-date with state-of-the art applied statistical methodology</li></ul>Impact:The Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.Success Factors:&nbsp;Effectively demonstrates fully functioning capability in the following areas:<ul><li>Urgency</li><li>Innovation</li><li>Passion</li><li>Inclusion</li><li>Accountability</li><li>Integrity</li></ul>GBS Leadership Success Factors:<ul><li>Leading and Managing Change</li><li>Influence and Impact Relationships</li><li>Decision Making</li><li>Building a Learning Environment</li><li>Emotional Intelligence</li><li>Managing and Developing Performance</li></ul>Education/Experience:<ul><li>Significant academic training in statistics, biostatistics or relevant areas of study. PhD degree in statistics or biostatistics or Master’s degree with relevant experience required.</li><li>&nbsp;Understanding of the application of biostatistics to medical/clinical trials data.</li><li>Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals</li><li>Excellent verbal and written communications skills.</li><li>Ability to be flexible and adapt quickly to the changing needs of the organization.</li><li>Ability to organize multiple work assignments and establish priorities.</li><li>Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.</li></ul>Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.&nbsp;Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.&nbsp; Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.&nbsp; This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Associate Director, Biostatistics

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.&nbsp;In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Key Responsibilities<ul><li>Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy</li><li>Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols.</li><li>Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents</li><li>Presents summary data and analyses results, in a clear, concise, complete, and transparent manner</li><li>Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information</li><li>Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area</li><li>Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development</li><li>Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design.</li><li>Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process</li><li>Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable</li><li>Contributes to external and internal statistical community of practice</li><li>Develops &amp; advises team members</li><li>Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.</li><li>Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.</li></ul>Applicable to people managers&nbsp;<ul><li>Effectively engages as an employee advocate and management coach/mentor to team members - both internally and externally</li><li>Provides leadership to empower and develop the team.</li><li>Provides guidance to employee's development plans and carries out performance review and feedback. develops performance metrics for staff.</li></ul>Qualifications &amp; Experience<ul><li>PhD (6+ years’ experience) or MS (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience</li><li>Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing &amp; simulation.</li><li>Great interpersonal, communication, writing and organizational skills</li><li>Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework</li><li>Good understanding of regulatory landscape and experience with participating in regulatory interactions</li><li>Demonstrate collaboration, organizational/ leadership abilities, and interpersonal skills</li><li>Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills</li><li>People manager experience is preferred (for people manager position only)</li></ul>Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.&nbsp;Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.&nbsp; Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.&nbsp; This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.&nbsp;In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Position Objective:Provide strategic direction to effectively drive the development and implementation of the regulatory documentation strategy to deliver key R&amp;D business objectives, support “speed to patient”, and facilitate submissions of investigational applications for early development of new molecular entities (NMEs) in the intended key markets. Provide leadership in planning and supporting the regulatory submission(s) by Early Development teams (EDT), and align with Early Development Committee (EDC) on prioritization and execution of overall global development strategy.Expected Areas of Competence:Submission Strategy:1. Develops and communicates strategic direction for worldwide regulatory documentation in support of investigational applications in alignment with BMS R&amp;D goals and objectives.2. Implements regulatory documentation standards that support speed and consistency of regulatory submissions across all assets and geographies.3. Drives regulatory documentation strategy and processes to ensure timely submission of investigational applications for early development of NMEs in the intended key markets in accordance with BMS R&amp;D objectives and commercial priority.4. Facilitate transition between early and full development with emphasis on speed-to-patient and high-velocity projects5. Champions the GSRD organization across multiple functions and identifies meaningful synergies.6. Identifies opportunities to participate / influence regulatory policy and climate with respect to documentation and dossier presentation in support of project goals and BMS preferences.7. Applies knowledge of internal and external guidances in providing feedback to the EDTs on issues related to regulatory documentation.Execution:1. Proactively addresses business need, prioritization of regulatory submissions, and allocates resources to meet strategic BMS R&amp;D early development goals.2. Contributes to the development of effective documentation processes and standards; ensures (i) implementation of the processes that support EDT goals and (ii) maintenance of BMS R&amp;D good documentation principles and standards.3. Implements major BMS R&amp;D-wide change management initiative to improve cycle time and quality of regulatory documentation for global investigational applications.4. Reviews project-specific story boards, prototypes, and model documents, as needed.5. Advises and authors complex clinical documents (e.g. IBs, Phase 1/2 clinical study reports, high-level summary documents, background documents) for timely submission to health authorities worldwide6. Proactively reviews progress against the investigational application/dossier plans, leads group members in identifying opportunities and threats in terms of documentation activities, and drives potential solutions with key team members.7. In conjunction with appropriate disciplines, identifies and ensures management of external documentation when required for in-licensed asset packages.8. Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documentsKnowledge Desired:(3-5 pre-hire areas of knowledge)1. PhD/MD/PharmD in a relevant scientific discipline, or MS/BS with thorough understanding of scientific principles and hypothesis testing and at least 5 years of pharmaceutical regulatory documentation.2. Analyzed and interpreted complex data from a broad range of scientific disciplines, including pharmacokinetics, pharmacodynamics, ECG, immunogenicity, bioanalytical and pediatric reporting requirements.3. Thorough understanding of global pharmaceutical drug development, both non clinical and clinical, and requirements for submission of regulatory dossiers for investigational applications to global health authorities.4. Broad knowledge of the pharmaceutical industry and major worldwide regulatory agencies, including their process and organization.5. Thorough understanding of the US and EU regulatory requirements; good understanding of Japanese and other major international regulatory requirements and procedures with an emphasis on early development deliverables to facilitate global readiness of full development program.Experiences Desired:(5-7 pre-hire ideal experiences)1. Prior early development clinical trial experience preferred, with an emphasis on PK, PD, ECG, immunogenicity, bioanalytical, and pediatric reporting requirements.2. At least three major submissions (IND/CTx/NDA/MAA/J-NDA), preferably in different therapeutic areas and a strong depth and breadth of knowledge of the submission process and significant experience in writing high-level summary documents for global registrations.3. Exhibits solid behaviors in cross-functional collaboration and communication.4. Experience working with FDA/EMEA/PMDA/TGA/SFDA on a wide range of issues including responding to questions, project-related meetings, and Advisory Committee meetings5. Experience in the areas of state-of-the-art documentation processes and technology.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.&nbsp;Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.&nbsp; Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.&nbsp; This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

60 Leadership / Executive Board Jobs in New Jersey