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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.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.

Bristol Myers Squibb

Director, Translational Development Program Manager, Solid Tumor

<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 Clearway Energy Group’s vision is a world powered by clean energy. Along with our public affiliate Clearway Energy, Inc., our portfolio comprises approximately 11.8 GW of gross generating capacity in 26 states, including 9.1 GW of wind, solar, and battery energy storage assets, and over 2.8 GW of flexible 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 2 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. 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 for 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, 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 - Wind

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.

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.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.

Associate Director, EDT Documentation Lead, Early Development

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.

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.PurposeThe Associate Director, Biostatistics is a core member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions and publications. Statisticians develop collaborative relationships and work effectively with the Global Biometric Sciences (GBS) Lead, the GBS Planning and Execution Lead, statistical programmers, external partners, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.Primary Responsibilities<ul><li>Core member of an EDT and key sub-teams. Contributes to all aspects of the development strategy.</li><li>Independently leads the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.</li><li>Participates in development strategy, protocols and analysis plans reviews.</li><li>Participates in continuous improvement initiatives.</li><li>Invests in knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments that impact the development teams.</li><li>Engages as a matrix team member on protocol teams as a scientific partner in the drug development process.</li><li>Ability to present summary data and analyses to key stakeholders in a clear, concise, complete and transparent manner.</li><li>Possesses technical knowledge of statistical methodology and ability to appropriately apply it in trial design and data analysis for clear, concise, high-quality results.</li><li>Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.</li></ul>Education/Experience<ul><li>PhD degree in Statistics or Biostatistics or Master’s degree with 7+ years' of relevant Pharmaceutical/R&amp;D or other related experience, including supporting regulatory filings.</li><li>Demonstrated knowledge of statistical / clinical trials methodology as it relates to clinical development.</li><li>Relevant prior data analysis planning, execution and delivery experience.</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>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, including the resolution of conflicts or their appropriate escalation</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.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.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.PurposeThe Associate Director, Biostatistics is a core member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions and publications. Statisticians develop collaborative relationships and work effectively with the Global Biometric Sciences (GBS) Lead, the GBS Planning and Execution Lead, statistical programmers, external partners, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.Primary Responsibilities<ul><li>Core member of an EDT and key sub-teams. Contributes to all aspects of the development strategy.</li><li>Independently leads the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.</li><li>Participates in development strategy, protocols and analysis plans reviews.</li><li>Participates in continuous improvement initiatives.</li><li>Invests in knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments that impact the development teams.</li><li>Engages as a matrix team member on protocol teams as a scientific partner in the drug development process.</li><li>Ability to present summary data and analyses to key stakeholders in a clear, concise, complete and transparent manner.</li><li>Possesses technical knowledge of statistical methodology and ability to appropriately apply it in trial design and data analysis for clear, concise, high-quality results.</li><li>Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.</li></ul>Education/Experience<ul><li>PhD degree in Statistics or Biostatistics or Master’s degree with 7+ years' of relevant Pharmaceutical/R&amp;D or other related experience, including supporting regulatory filings.</li><li>Demonstrated knowledge of statistical / clinical trials methodology as it relates to clinical development.</li><li>Relevant prior data analysis planning, execution and delivery experience.</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>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, including the resolution of conflicts or their appropriate escalation</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.

About Pacira&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Why work with us?&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.&nbsp; At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.Summary:Reporting to the Executive Director, Clinical Operations, this position provides clinical trial contracts and budget expertise to Clinical Development Operations at Pacira BioSciences. The position will need to frequently interact with legal, as well as other constituents within Pacira and externally to ensure complete alignment with respect to contract development and execution for clinical trials and related agreements.Essential Duties &amp; Responsibilities:The following statements are intended to describe the general nature and level of work being performed by anindividual assigned to this job. Other duties may be assigned.<ul><li>Negotiate contracts, change orders, and renewals</li><li>Create standards for vendors, including governance and oversight model, tools, templates</li><li>Aid the Clin Ops team in finding the best available vendors</li><li>Participate in vendor governance meetings</li><li>Coordinates the development and agreement of the site MSA/CSA</li><li>Accountable for the site negotiation and execution of site clinical trial agreements and budgets within agreed upon terms </li><li>Assist in resolving negotiation barriers and issue resolution to ensure timely execution of CTAs</li><li>Review site consent form template revisions to verify consistency with the site budget and CTA.</li><li>Interface with legal to facilitate and resolve any contracts negotiation items</li><li>Escalates budget and contract related issues to the project team and/or management, and assists in resolution</li><li>Contributes to departmental and responsible for trial-level budgets including forecasting, accruals, etc.</li><li>Responsible for Pacira Pharmaceuticals compliance with all applicable regulatory standards related to US and global clinical trials and interactions with physicians including but not limited to Sunshine Act.</li><li>Support the Executive Director with assignment of appropriate departmental representation on Project Teams, Study Teams, and cross-functional initiatives. Responsible for identification of innovative solutions that enable efficiency, effectiveness, and quality that help drive the clinical development process.</li><li>Contribute to the development of scalable capabilities that will allow for future growth with a view toward identifying core/non-core activities and a plan to retain those of strategic importance in-house.</li><li>Support the Executive Director in development of CRO sourcing strategy (including core/non-core definition) specific to Clinical Operations; actively work towards improvements over time that drive improvements in time, cost, and quality.</li><li>Support the Executive Director in providing updates and status reports to Executive/Senior Management on a regular basis to include performance against the plan. </li><li>Facilitate and maintain relationships between Pacira Biosciences and vendors/partners.</li><li>Other duties as assigned.</li></ul>Supervisory Responsibilities:This position may have supervisory responsibilities.Interaction:The incumbent works closely with internal and external partners to provide clinical trial contracts expertise.Education and Experience:<ul><li>Bachelor’s degree from accredited college or university, or equivalent experience; advanced degree preferred.</li><li>Minimum 10 years of experience in pharmaceutical / medical device industry</li><li>Experience in conduct of hospital or clinic-based clinical research trials</li></ul>Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knowledge, Skills, and Abilities:<ul><li>Manage contracts and budgets (including change orders) with sites, CROs and vendors.</li><li>Negotiate contracts to optimize costs and timelines, in coordination with legal and finance to pre-agreed terms/parameters.</li><li>Vendor relationship liaison for the Clinical Development Operations organization. </li><li>Exceptional relationship management skills and strong financial acumen.</li><li>Experience drafting and negotiating contracts such as master service agreements, statements of work, confidentiality agreements, supply agreements, consulting agreements, clinical trial and related agreements, and other corporate pharmaceutical-related agreements is required.</li><li>Knowledge of contract law and effective communication, negotiation, and the ability to influence and work collaboratively at all levels and across functions.</li><li>Must have experience with clinical trial agreements, confidentiality agreements and informed consent agreements.</li><li>Proven ability to manage multiple projects, set priorities and meet deadlines.</li><li>Excellent skill level in MS Office including Word, Excel, and Outlook.</li><li>Demonstrated commitment to working within Regulatory and Compliance constructs.</li><li>Excellent written and oral English communication and presentation skills with excellent professional demeanor and presence.</li><li>Strong MS Office Skills.</li><li>Ability to work effectively on a team in an entrepreneurial environment with proven ability to forge cross-functional working relationships with internal/external teams including legal, finance, procurement, sites, and vendors</li><li>Strong project planning, leadership, and negotiation skills as well as an ability to contribute creative yet practical solutions/resolutions to problems.</li><li>Demonstrated ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of clinical trials and resolve the issues in a timely fashion.</li></ul>Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.The ability to function independently utilizing remote office tools and work in a team environment; requires occasional travel to company locations and may require occasional on-site presence at clinical trial sites.Benefits:<ul><li>Medical, Prescription, Dental, Vision Coverage</li><li>Flexible Spending Account &amp; Health Savings Account with Company match</li><li>Employee Assistance Program</li><li>Mental Health Resources</li><li>Disability Coverage</li><li>Life insurance</li><li>Critical Illness and Accident Insurance</li><li>Legal and Identity Theft Protection</li><li>Pet Insurance</li><li>Fertility and Maternity Assistance</li><li>401(k) with company match</li><li>Flexible Time Off (FTO) and 11 paid holidays</li><li>Paid Parental Leave</li></ul>

Pacira Biosciences Inc.

Associate Director, Clinical Contracts/Budget

About Pacira&nbsp;Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Why work with us?&nbsp;Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.&nbsp; At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.&nbsp;&nbsp;Summary:The Director, FP&amp;A Manufacturing will lead Financial Planning and Analysis (FP&amp;A) for manufacturing and capital expenditures. This role focuses on delivering timely, accurate, and insightful information to Finance and business leaders. &nbsp;&nbsp;Responsibilities include ongoing an ad-hoc analysis, supporting monthly and quarterly financial management reporting, reviewing and summarizing Budgets, Forecasts and Long-Range Planning for relevant areas. Essential Duties &amp; Responsibilities:<ul><li>Consolidate manufacturing budgets, forecasts and long-range planning, which involves gathering key assumptions and preparing presentations</li></ul><ul><li>Develop, maintain, and update models and reports, such as long-range planning model, gross margin landing model, and guidance and analytics models</li><li>Lead process and system initiatives for relevant areas to automate reports and streamline processes</li><li>Lead manufacturing planning activities including:</li><ul><li>Offer insights into cost savings activities and drive cost reduction initiatives</li><li>Participate in contract reviews ensuring a thorough understanding of key terms and conditions</li><li>Support business decisions through financial analysis and modeling</li></ul></ul><ul><li>Assist with the monthly close process including reviewing departmental accruals and variance analysis related to contract manufacturing activities, </li><li>Lead the Capital Expenditure process:</li><ul><li>Oversee Capital Expenditures including reviewing and guiding for Capital Appropriation Requests (CAR), preparing forecasts for capital expenditure and depreciation, and coordinating explanations for variances</li><li>Manage the Capital Committee by scheduling meetings, assisting with preparation of presentations, and distributing meeting minutes</li><li>Secure approval of standard forms related to capital expenditure requests, transfers, and retirement&nbsp;&nbsp; </li><li>Coordinate and review monthly accruals for construction in progress, reclassifications, and placing assets in service</li></ul></ul><ul><li>Manage inventory intercompany process, which includes maintaining transfer prices for intercompany sales, monitoring inventory activity to ensure proper elimination of intercompany transactions, and preparing eliminations entries as necessary</li><li>Participate in the annual audit and inventory counts, ensuring adherence to finance and accounting policies consistent with GAAP and SEC requirements and compliance with SOX 404 standards</li></ul><ul><li>Other ad hoc analysis and projects as deemed appropriate</li></ul>Supervisory Responsibilities:This position does not have any direct reports.Interaction:The incumbent works closely with Site Controllers, Corporate FP&amp;A, Corporate Accounting, and Operations Management. Education and Experience:<ul><li>Bachelor’s degree in accounting or finance from accredited college or university; CPA or MBA a plus</li><li>Minimum 10 years of experience in financial analysis, management reporting, financial planning/budgeting or related area</li><li>System experience in forecasting (e.g., OneStream)</li><li>Pharmaceuticals experience a plus</li></ul>Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Knowledge, Skills, and Abilities:<ul><li>Demonstrated working knowledge of budgeting, financial analysis, general accounting</li><li>Excellent skills in Microsoft Office including Word, Excel, and Outlook</li><li>High proficiency in planning and reporting software (e.g., OneStream)</li><li>Demonstrated current knowledge of GAAP and a thorough understanding of cost accounting, preferably in pharmaceutical industry</li><li>Demonstrated excellent analytical abilities and effective oral and written communication skills</li><li>Experience working in a fast-paced environment with multi-project and multi-product manufacturing organization</li><li>Proven ability to manage multiple projects, set priorities and meet deadlines</li><li>Demonstrated problem solving skills</li><li>Ability to travel up to 5%.</li></ul>Work Environment:The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles. Benefits:<ul><li>Medical, Prescription, Dental, Vision Coverage</li><li>Flexible Spending Account &amp; Health Savings Account with Company match</li><li>Employee Assistance Program</li><li>Mental Health Resources</li><li>Disability Coverage</li><li>Life insurance</li><li>Critical Illness and Accident Insurance</li><li>Legal and Identity Theft Protection</li><li>Pet Insurance</li><li>Fertility and Maternity Assistance</li><li>401(k) with company match</li><li>Flexible Time Off (FTO) and 11 paid holidays</li><li>Paid Parental Leave</li></ul>

Director, FP&A - Manufacturing

About Pacira&nbsp;&nbsp;&nbsp;&nbsp;Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.&nbsp;Why work with us?&nbsp;&nbsp;&nbsp;&nbsp;Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.&nbsp; At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.&nbsp;&nbsp;&nbsp;Summary:The Executive Director, Market Access Operations will spearhead the strategic oversight and operational excellence of market access initiatives, encompassing comprehensive management of product distribution across all trade channels. This role will drive the strategic deployment and tactical execution of distribution strategies for Exparel, iovera and ZILRETTA, including Deal Desk operations, pricing input, and contract management. The Executive Director will be pivotal in fostering and cultivating robust customer relationships and will lead the development and execution of business plans tailored to trade channel stakeholders such as wholesalers, distributors, and specialty pharmacies. Additionally, this individual will chair the pricing and contracting subcommittee, providing high-level guidance and ensuring alignment with organizational goals.Essential Duties &amp; Responsibilities:The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.<ul><li>Co-Develops, executes, and tracks the GPO, IDN, and payer strategy along with the SVP of Market Access, the Executive Director of National Accounts and ED of payer accounts to optimize the patient experience for all products requiring physical distribution within assigned accounts</li><li>Leads all aspects of wholesale/distributor account business planning and execution aligned to channel management operating plan including scheduling business meetings and leading agenda setting</li><li>Ensures product stocking goals are met to support new product launch and ongoing business needs with all accounts</li><li>Effectively leads, negotiates, and manages all distribution/wholesaler agreements and proposes favorable contract terms and evaluates opportunities to continue to drive business through our wholesale and specialty distributor partners with pricing/contracting committee review/approval.</li><li>Partnering with National Accounts and payer accounts to develop effective strategies to maximize business opportunities and review and provide input on customer contracts;</li><li>Manages a trade operations team responsible for:</li><ul><li>Ensuring customer sales occur within terms and conditions of negotiated agreements and providing timely solutions to any issues that may arise;</li><li>Reviewing sales and chargeback transactions to ensure alignment to contracts, eligibility, and compliance with the company’s chargeback policy; Managing day to day relationships and conduct business reviews in conjunction with Finance and Commercial Operations, with all wholesalers and specialty distributors to resolve issues associated with unapplied chargebacks, rebates, promotions, and other operational challenges;</li><li>Working cross-functionally with finance, data analytics, and field operations team;</li><li>Analyzing sales data and providing timely information to support chargeback accruals for quarter and annual closes;</li><li>Facilitating the timely resolution of issues associated with accounts receivable aged outstanding balances, including working with third party logistical provider (3PL) and internal stakeholders, to address issues such as short payment, unauthorized deductions, aged outstanding balances, unapplied/open credits;</li><li>&nbsp;Managing the relationship with 3PL service provider including coordinating business reviews, ensuring timely receipt of sales and chargeback data, timely shipping, exceptional customer service, processing of returns, etc.</li></ul><li>Sets recommendations to the pricing/contracting committee on Deal Desk pricing matrix and any potential recommendations outside said matrix</li><li>Manages the contract administrations and works closely with sales operations on data analytics on success factors</li><li>Develops and ensures completion of annual plan for assigned key customer accounts and keep management informed about progress and team members engaged in plan deliverables. Include cross-functional teams.</li><li>Evaluates, provides input, collaborates cross functionally, and executes end user customer contracting process as well as assessing the long-term value impact</li><li>Acts as the primary contact points for each customer to facilitate resolution of issues, support new product launches, and enable pharmacy programs/collaborations via wholesale distribution</li><li>Maximize process efficiencies, ensure processes have effective internal controls and meet business needs on a timely basis&nbsp;</li></ul>Supervisory Responsibilities:&nbsp;This position has supervisory responsibilityEducation and Experience:<ul><li>Bachelor's degree minimum required; MBA preferred</li><li>Minimum 15 years of experience in the pharmaceutical industry with &nbsp;demonstrated channel management in Trade distribution experience</li></ul>Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Knowledge, Skills, and Abilities:<ul><li>Deep knowledge of product markets in the pharmaceutical industry</li><li>Knowledge of and experience with channel management (Wholesaler/Specialty Distributor/3PL, GPO, Hospital, Payer)</li><li>Highly motivated, demonstrated excellent analytical abilities and effective oral and written communication skills</li><li>Pricing and contracting experience preferred.</li><li>Demonstrated ability to work cross functionally in a supportive team environment.</li><li>Ability to prioritize multiple tasks/requirements.</li><li>Advanced Microsoft Excel and PowerPoint skills</li><li>Ability to travel 30-40%</li></ul>Physical Demands:The physical demands described here are representative of those that must me met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop.&nbsp; Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.&nbsp;Position will be based remotely. Employee will work from his/her home office setting and occasionally from a Pacira Corporate office setting.Benefits:<ul><li>Medical, Prescription, Dental, Vision Coverage</li><li>Flexible Spending Account &amp; Health Savings Account with Company match</li><li>Employee Assistance Program</li><li>Mental Health Resources</li><li>Disability Coverage</li><li>Life insurance</li><li>Critical Illness and Accident Insurance</li><li>Legal and Identity Theft Protection</li><li>Pet Insurance</li><li>Fertility and Maternity Assistance</li><li>401(k) with company match</li><li>Flexible Time Off (FTO) and 11 paid holidays</li><li>Paid Parental Leave</li></ul>

83 Leadership / Executive Board Jobs in New Jersey