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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. 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 Associate Director of Biostatistical Programming at RayzeBio will be accountable for development of clinical study related deliverables and timelines, oversee study vendors' programming deliverables, and support company internal requests. The successful candidate will report to the Head of Biostatistical Programming.Job ResponsibilitiesEssential duties and responsibilities include the following.&nbsp; Other duties may be assigned.<ul><li>Oversee vendors' activities, and review vendors' deliverables to ensure quality</li><li>Create/QC SDTM/ADaM data specifications, create/QC CDISC datasets and provide/QC outputs based on protocols/SAP</li><li>Participate in reviewing, analyzing, and reporting clinical trial data and generating outputs to support DSUR/IBs, publications, FDA meeting briefing documents, and other internal ad-hoc requests</li><li>Collaborate with cross-functional teams to review critical study documents and perform data reviews for ongoing studies</li><li>Oversee CDISC data package development for clinical studies to support CSRs and future regulatory submissions</li><li>Create SAS macros/applications to streamline processes and enhance efficiency</li></ul>Education and Experience<ul><li>A bachelor's degree required in statistics, mathematics or equivalent with at least 10 years’ experience in pharmaceutical industry; or a master's degree in statistics or computer science with at least 7 years’ programming experience is preferred.</li><li>Oncology therapeutic area experience required.</li><li>Proven ability to manage CRO relationships and oversee programmed deliverables.</li><li>Advanced skills in SAS programming and statistical reporting.</li><li>In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements.</li><li>Advanced Knowledge with FDA and ICH regulations and guidelines, and clinical trial methodologies.</li><li>Good written and verbal communication skills.</li><li>Be able to work productively in a fast-paced collaborative environment.</li><li>Willing to travel approximately 10% of the time.&nbsp; Evening and weekend work will be involved.</li></ul>Physical demandsWhile performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.Work&nbsp;EnvironmentThe noise level in the&nbsp;work&nbsp;environment is usually moderate.The starting compensation for this job is a range from&nbsp;$190,600 - $230,900 plus incentive cash and&nbsp;stock&nbsp;opportunities&nbsp;(based on&nbsp;eligibility).&nbsp;The&nbsp;starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.&nbsp;Final, individual compensation will be decided based on demonstrated experience.&nbsp;Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as 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. 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. 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.&nbsp;&nbsp;#RayzeBioIf 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 a supportive culture, promoting global participation 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 an 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

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. 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.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.Job Responsibilities:The Associate Director of Human Resources is responsible for driving HR strategies that support workforce planning and culture engagement initiatives, ensuring alignment with company objectives. Additionally, the Associate Director will support the oversight of recruitment within a shared services model and ensure HR compliance with federal, state, and local labor laws. The role is key to fostering an inclusive, high-performance workplace culture and supporting organizational success through strategic HR practices. This role is based in San Diego, CA and reports to the Head of Human Resources. Essential duties and responsibilities include the following. Other duties may be assigned.HR Strategy and Planning:<ul><li>Provide guidance on HR best practices, employee relations, and workforce strategies.</li><li>Act as a trusted advisor for managers on employee-related issues, driving effective employee relations, engagement, and culture-building efforts.</li><li>Contribute to HR strategy development and implementation, supporting the workforce in achieving company goals through effective workforce planning and employee engagement.</li><li>Develop and implement HR initiatives that align with the company's growth objectives and scientific innovation goals.</li><li>Analyze HR metrics and data to inform strategic decisions and improve HR processes and outcomes.</li></ul>Employee Relations:<ul><li>Support the resolution of complex employee relations issues, investigations, and grievances.</li><li>Proactively address workplace issues, ensuring compliance with employment laws and internal policies.</li><li>Provide coaching to managers on performance management, conflict resolution, and disciplinary actions.</li></ul>Learning and Development:<ul><li>Support learning and development initiatives, helping to identify training needs and create relevant programs to enhance employee skills and leadership development.</li><li>Facilitate programs aimed at career growth and continuous learning, ensuring alignment with business objectives.</li></ul>Culture Engagement:<ul><li>Support the development and implementation of employee engagement strategies to enhance workplace culture and foster employee involvement.</li><li>Lead initiatives that promote a positive workplace environment and align with company values.</li></ul>Recruitment Oversight:<ul><li>Provide support of the oversight of recruitment processes within a shared services model, ensuring alignment with organizational needs and standards.</li><li>Work with the recruitment team to support key hires, though not involved in the day-to-day recruitment activities.</li></ul>HR Compliance:<ul><li>Ensure full compliance with federal, state, and local labor regulations, maintaining up-to-date knowledge of HR policies and best practices.</li><li>Oversee the implementation of HR policies and procedures across the Indianapolis site.</li><li>Collaborate with legal and compliance teams to mitigate risk and ensure consistency in HR operations.</li></ul>Basic Qualifications:<ul><li>Bachelor’s degree in Human Resources, Business Administration, or a related field </li><li>7+ years of HR experience with significant exposure to employee relations, HR compliance, learning and development, and culture engagement. </li><li>Proven experience in working effectively within a matrixed environment and building alignment in a cross-functional and team environment </li></ul>Preferred Qualifications: <ul><li>Masters degree </li><li>Experience in life sciences manufacturing</li></ul>Skills and Qualifications:<ul><li>Expertise in employee relations, compliance, and HR best practices.</li><li>Strong communication and interpersonal skills, with the ability to influence and build relationships at all levels.</li><li>Demonstrated ability to foster a high-performance, engaged workplace culture.</li><li>Proven experience in working effectively within a matrixed environment and building alignment in a cross-functional and team environment </li></ul>The starting compensation for this job&nbsp;is a range is from $ 182,753.00 to&nbsp; $221,500.00 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 based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>.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.#RayzeBioIf 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 a supportive culture, promoting global participation 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 an 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, Human Resources

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. As Lundbeck’s North American hub for early-stage drug discovery, the Lundbeck La Jolla Research Center positions our company to deliver transformative treatments for brain disease. Join us on our journey of discovery! POSITION SUMMARY:The Director, Chemical Biology leads a world-class team researching new understandings of the behavior of biological systems and their interactions with small molecules, in order to populate the portfolio with high value targets and novel mechanisms and to deliver and characterize new chemical entities.&nbsp; This position works with a high degree of independence to devise and communicate the strategy of the team, is accountable for the team’s execution of that strategy, works collaboratively with many global functions and projects within Research, and is responsible for supervising and mentoring the members of the team, who themselves are leaders of various sub-functions spanning multiple projects.ESSENTIAL FUNCTIONS:<ul><li>Leads a multi-disciplinary team in devising and executing company’s innovative chemical biology strategy</li><li>Introduces specific targets into the Research portfolio and oversees their progression to early milestones</li><li>Leads the design and synthesis of high-quality small molecule tools and early hits</li><li>Working closely with project teams, utilizes the Platform Technologies capabilities to accelerate the optimization of hits into lead compounds</li><li>Directs the integration of chemical biology into all research programs as appropriate</li><li>Implements leading edge chemo- and bio-informatics infrastructure to advance data management &amp; visualization</li><li>Identifies and implements state of the art instrumentation and automation</li><li>Oversees chemistry activities at Contract Research Organizations (CROs)</li><li>Contributes to objective setting for team and site</li><li>Trains and mentors a team of varying skill and experience levels</li><li>Contributes to publications in peer-reviewed journals, presents work at scientific conferences, and prepares patent applications</li><li>Identifies and executes on opportunities to collaborate externally</li><li>Informs on BD activities</li></ul>REQUIRED EDUCATION, EXPERIENCE, and SKILLS:<ul><li>PhD from an accredited university</li><li>10+ years' experience in chemical biology</li><li>3+ years' working knowledge of chemical biology and experience in planning, developing, and executing relevant experiments</li><li>3+ years' working knowledge of synthetic organic chemistry and medicinal chemistry strategies and problem solving, related to design of small molecule therapeutics</li><li>Ability to develop, implement, and clearly communicate strategies to team, management, and collaborators</li><li>Excellent collaboration, communication, and presentation skills.</li><li>Skilled team player, flexible, and able to handle multiple tasks and deliver high quality results under tight timelines</li><li>Thrives in a team environment of shared goals and responsibilities</li></ul>PREFERRD SKILLS:<ul><li>Working knowledge of chemo proteomics</li><li>Background in biological assay development</li><li>Proven skills in covalent chemistry&nbsp; </li><li>Recent exposure to Activity Based Protein Profiling (ABPP)</li><li>Experienced leader of project teams and mentor to junior staff</li></ul>TRAVEL:<ul><li>Willingness/Ability to travel up to 10%.</li></ul>The range displayed is specifically for those potential hires who will work or reside in the state of California, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $240,000 - $275,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis.&nbsp;Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

Lundbeck

Director of Chemical Biology

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. 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.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.The Senior Medical Director – Clinical Development has responsibility for the clinical development of targeted radiopharmaceuticals for treatment of solid tumors, with a focus on GU cancers. This role provides medical direction and high quality scientific and clinical knowledge to lead the strategy and execution of RayzeBio’s clinical development plans in GU cancers. Responsibilities include support for IND preparation, regulatory authority interactions, design and execution of Phase 1 to Phase 3 clinical trials, and medical monitoring. This role works collaboratively with cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio’s portfolio to ensure the program meets the needs of patients and RayzeBio’s business. This role can be based onsite in either San Diego, CA or Lawrenceville, NJ.Responsibilities: <ul><li>Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates</li><li>Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies</li><li>Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents</li><li>Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators</li><li>Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets</li><li>Translate findings from research and nonclinical studies into clinical development opportunities</li><li>Oversee Data Review and Independent Data Monitoring Committees</li><li>Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines</li><li>Establish and maintain positive relationships with clinical trial investigators and thought leaders</li><li>Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings.</li><li>Supervise and mentor clinical scientists and medical directors</li><li>Willing to travel approximately 30% of the time.&nbsp;</li></ul>Education and Experience<ul><li>MD or equivalent with sub-specialty training in oncology and at least 8 years of pharmaceutical/biotech in oncology solid tumor clinical development or equivalent academic experience. Radiopharmaceutical experience is preferred but not required.</li><li>Drug development experience in GU cancer required.</li></ul>Skills and Qualifications<ul><li>Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics</li><li>Motivated to work in a fast-paced, high accountability, small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills.</li><li>Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.</li><li>Demonstrated ability to collaborate successfully with multiple functions in a team environment.</li><li>Intellectually curious with courage to challenge and seek new ways to improve work.</li><li>Strong written and oral communication skills, including presentation skills.</li><li>Ability to analyze and interpret data and develop written reports and presentations of those data.</li><li>Strong critical, strategic, and analytical thinking skills.</li><li>Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis and reporting.</li><li>Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials.</li><li>Skilled in clinical research and understand the process of pharmaceutical product development and approval.</li><li>Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).</li><li>Solid understanding of GCP and ICH guidelines.</li></ul>Physical demandsWhile performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.Work&nbsp;EnvironmentThe noise level in the&nbsp;work&nbsp;environment is usually moderate.The starting compensation for this job&nbsp;is a range in San Diego, CA, is from $331,359 to $401,500 and in Lawrenceville, NJ, is from $306,814 to $371,800 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 based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>.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.#RayzeBio#LI-OnsiteIf 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 a supportive culture, promoting global participation 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 an 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. Medical Director, Clinical Development

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. 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.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.The Executive Director, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all aspects of product safety across clinical development and post-marketing surveillance. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution of safety science to protect patient health and optimize product benefit-risk profiles. The ED works cross-functionally with clinical, regulatory, medical affairs, quality, and commercial teams to support the safe use of products globally.Job ResponsibilitiesEssential duties and responsibilities include the following.&nbsp; Other duties may be assigned.<ul><li>Pharmacovigilance Strategy and Oversight</li><li>Develop and lead the global pharmacovigilance strategy to ensure proactive risk management and compliance with local and international PV regulations (e.g., FDA, EMA, ICH).</li><li>Oversee safety operations team members and vendors in managing end-to-end PV activities, including case processing, safety surveillance, risk management, aggregate reporting and signal detection and assessment.</li><li>Establish and maintain robust safety governance structures and standard operating procedures, ensuring alignment with company objectives and industry best practices.</li><li>Ensure collaboration with BMS safety and clinical development leadership</li><li>Safety Science and Risk Management</li><li>Direct safety evaluation and risk management for clinical development and post-marketing products, including benefit-risk assessments and product safety strategy.</li><li>Lead the detection, evaluation, and management of safety signals, collaborating with cross-functional teams to implement risk minimization strategies and communicate potential safety concerns.</li><li>Represent safety science for health authority interactions and drive safety related content of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.</li><li>Contribute to understanding and managing the AE profile of products in development and ensure protocols ensure appropriate safety management in all phases of clinical trials</li><li>Lead the strategy and review of safety modules and risk management plans in regulatory filings</li><li>Contribute to the development of risk/benefit analyses in regulatory filings and HTA submissions</li><li>Cross-Functional Leadership and Stakeholder Engagement</li><li>Partner with clinical, regulatory, and medical affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies.</li><li>Act as the key PV representative for interactions with global regulatory authorities and stakeholders, advocating for patient safety.</li><li>Engage with external experts, scientific bodies, and industry groups to stay updated on evolving PV practices and enhance the organization’s safety profile.</li><li>Team Leadership and Development</li><li>Lead and mentor a high-performing pharmacovigilance team, fostering a culture of collaboration, accountability, and scientific excellence.</li><li>Define and implement processes for continuous improvement within safety science, and risk management.</li></ul>Basic Qualifications:<ul><li>MD or equivalent (MBBS etc) </li><li>10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry, </li><li>Oncology experience </li><li>Experience with global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH</li><li>Demonstrable understanding of clinical development, post-marketing safety, and regulatory submissions</li><li>Demonstrated expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting.</li><li>Experience interacting with global regulatory authorities and scientific advisory bodies</li></ul>Preferred Qualification<ul><li>Radiopharmaceutical experience </li></ul>Skills and Qualifications<ul><li>Strong leadership and communication skills.</li><li>Proven ability to work effectively in a matrixed, cross-functional environment.</li><li>Demonstrated commitment to patient safety and ethics in medical practice.</li><li>25% travel </li></ul>Physical DemandsWhile performing the duties of this&nbsp;job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this&nbsp;job&nbsp;include&nbsp;close vision and distance vision.&nbsp;Work&nbsp;EnvironmentThe noise level in the&nbsp;work&nbsp;environment is usually moderate.The starting compensation for this job&nbsp;is a range from $284,730 to $334,980 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 based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>.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.#RayzeBio#LI-OnsiteIf 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 a supportive culture, promoting global participation 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 an 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.

Executive Director, Head of Pharmacovigilance - Safety Science

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.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Director, Medical Affairs Research Operations, plays an integral role in supporting the Medical Affairs team. This position provides operational and scientific support of investigator-initiated trials, to ensure their successful implementation. This individual is responsible for activities associated with activation, tracking, and reporting of study-related information. This role will work cross-functionally with several departments (Clinical Operations, CMC, Regulatory Affairs, Supply Chain, Drug Safety/PV, Compliance and Legal).Responsibilities: Essential duties and responsibilities include the following.&nbsp; Other duties may be assigned.<ul><li>Provide operational expertise and lead the Investigator Initiated Trial (IIT) program with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements</li><li>Conduct budget negotiations for Medical Affairs IITs, including fair market value assessments for all study related items. Create process for internal review of budgeting of trials</li><li>Maintain all internal records and databases associated with IIT program and develop reports when required</li><li>Create departmental SOPs and maintain these documents over time. Conduct training for cross-functional partners on appropriate processes</li><li>Ensure that processes allow for activation of studies in a timely fashion consistent with the developed SOPs. Assist in activation workflow to ensure all study timelines are met</li><li>Create IIT strategy with cross functional team members both within medical affairs as&nbsp;well as clinical development, clinical operations, regulatory, legal, etc</li><li>Collaborate with operations to ensure drug shipments, milestones, etc. are aligned to study specific timelines</li><li>Work with regulatory affairs to ensure that all investigator-initiated trials adhere to relevant regulatory guidelines, including IRB approvals and IND submissions</li><li>Maintain safety data from all trials to ensure patient safety and necessary documentation for any regulatory needs</li><li>Assess all IIT invoicing and perform budget reconciliation upon any changes within IIT protocols</li><li>Assist with other duties related to the operations of the IST program, including facilitation and management of cross-functional work-streams</li><li>Ability to travel (US and International) approximately 25% of time</li></ul>Education and Experience:<ul><li>Advanced degree (PhD, Pharm D, MD, DO, Advanced Nursing Degree, Advanced Degree in Health Sciences, MS, or equivalent) with 5+ yrs experience in leading an Investigator initiated trial (IIT) program in a pharmaceutical environment</li><li>Oncology experience required (GI oncology and radiopharmaceutical experience strongly preferred).</li><li>Demonstrated strong project management skills and leadership poise a must to negotiate and facilitate alignment amongst internal and external stakeholders (KOLs, internal cross-functional teams).</li></ul>Skills and Qualifications:<ul><li>Excellent and effective interpersonal and communication skills</li><li>Must be well organized and able to multi-task in a fast-paced deadline driven environment</li><li>Prior experience interpreting and implementing regulations and guidelines governing clinical trials</li><li>Advanced computer and Internet skills, including knowledge of MS applications (such as Word, PowerPoint, Teams, Excel), Veeva, electronic publication management tools, SharePoint, references databases, PubMed, etc.</li><li>Knowledge of information technology systems supporting medical affairs activities</li></ul>Physical Demands:<ul><li>While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.</li></ul>Work&nbsp;Environment:<ul><li>The noise level in the&nbsp;work&nbsp;environment is usually moderate.</li></ul>#RayzeBio#LI-OnsiteIf 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, Medical Affairs Research Operations

About Pacira 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.&nbsp;&nbsp;&nbsp;&nbsp;Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management.&nbsp;&nbsp;&nbsp;&nbsp;We have 700+ employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue. We are small enough for you to make your mark, and big enough for you to learn and grow!&nbsp;&nbsp;&nbsp;We have facilities in New Jersey, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&amp;D facility. We are rapidly growing and have opportunities across all of our sites and functional areas. Why work with us? 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. 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:This position is responsible for assigned regulatory projects to ensure regulatory compliance for approved marketing applications (NDA/MAA/NDS etc.) and leading to successful preparation of clinical trial applications (IND/CTA etc.). It also provides regulatory expertise to the Pacira Pharmaceuticals regulatory team.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>Prepare regulatory filings for submission to US and international health agencies in the areas of new drug development, marketing applications and approved product support. This would include IND applications, annual reports, Investigator brochures, and meeting requests</li><li>Ensure conformance to commitments made with various health agencies (e.g., IND/NDA/MAA/NDS commitments).</li><li>Propose and/or assist in developing regulatory strategies; identify and implement appropriate submission strategies for assigned projects.</li><li>Work with submission manager to ensure regulatory submissions are of high quality and submitted in a timely manner; review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.</li><li>Participate in Regulatory interaction and presentations to Regulatory Health Authorities, customers and partners.</li><li>Monitor and maintain awareness of regulatory environment assessing impact to business, interpret and disseminate information to affected departments.</li><li>Can act as regulatory affairs CMC liaison with partner companies and contract manufacturers</li><li>Other duties as assigned.</li></ul>Supervisory Responsibilities:This person may have direct supervisory responsibilities.Interaction:The incumbent works closely with employees in all functional areas of the company to provide regulatory guidance and support.Education and Experience:<ul><li>Bachelor’s degree in life science or related discipline required</li><li>Minimum 10 years of progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry required</li><li>Demonstrated strong understanding of the U.S. Regulatory requirements</li><li>Proven ability to interpret and apply regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements)</li><li>Excellent written and verbal English communication skills</li><li>Demonstrated organizational skills</li><li>Proven negotiation skills.</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></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.&nbsp; 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. Will need to lift and move boxes of paper and binders weighing up to 20 pounds.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. Typical office setting, noise level is moderate with consistent printer, telephone ringing and conversation.Travel Requirements:The job requires the employee to be able to travel between Pacira sites, to in person Agency meetings (FDA and International Authorities), and to visit contract organizations or cooperation partners. Approximately 25% travel.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>The base pay range for this role in California is $160,000 annually to $220,000 annually.&nbsp;The range is&nbsp;what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

7 Leadership / Executive Board Jobs in San Diego, CA, USA