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Director, Clinical Pharmacology and Pharmacometrics

The Director is responsible for ensuring clinical pharmacology support for a portfolio of assigned oncology therapeutic area projects.  This role includes the creation and implementation of optimized Clinical Pharmacology plans, incorporating established and innovative approaches. Leads a team of clinical pharmacologists in advancing early development programs through IND to clinical POC, and late stage development programs through NDA, BLA and MAA and post approval activities.  

The role will support projects at various stages of development, playing an active role in our drug discovery and development efforts to advance RayzeBio’s radiopharmaceutical pipeline.

Role and responsibilities

Serves as a key member of the CP&P leadership teamResponsible and accountable for assigned clinical pharmacology strategy within assigned projectsContributes to integrated strategy with R&ED, GDD, and CommercializationDirects clinical pharmacology scientists in the development of strategy and execution of clinical PK, PK/PD, pharmacometric analyses, and modeling & simulation (MS) plans Drives decision-making and strategy over the entire portfolio through effective partnership with partner functions and senior leadersOversees scientific output, conduct and resourcing of clinical pharmacology, PK/PD, working in concert with pharmacometrics and QSP functional partnersSupports strategy for dose selection, dose justification and regulatory filingsReviews and approves relevant scientific data and reports for regulatory filingsDevelops technical/leadership skills of clinical and MS scientists  Participates in, or assigns qualified delegates to support in-licensing and out-licensing business development activities Represents Clinical Pharmacology on relevant governance committees and works streams. Oversees planning, execution of clinical pharmacology trials in concert with clinical operationsRepresents the ClinPharm department on cross-functional disease strategy teams and on relevant governance forumsProvides input to Phase 2/3 clinical study design and registrational strategySupervises the development of the Clinical Pharmacology Plan(s)Supervises design of Clinical Pharmacology studies and manages data analysis, interpretation, and reportingCollaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives; serves as Clinical Pharmacology subject matter expert Represents the CP&P line and as Subject matter expert in interactions with health authoritiesMay work on key internal initiatives and serves as department representative on relevant external initiativesBuilds a team that is collaborative, supportive learning environment.

Requirements:

Ph.D. in pharmacokinetics/pharmaceutical science or relevant field; ORPharmD with post-doctoral training; Ph.D and PharmD should have at least 8-10+ years’ experience working in clinical pharmacology;   ORMS in pharmacokinetics/pharmacology or relevant field with 12-15 years experience working in clinical pharmacology.Extensive expertise in the application of clinical pharmacology in early and late stage drug development.Experience leading/managing a clinical pharmacology team/groupExperienced in applying advanced quantitative analysis and model informed drug development (MIDD) approachesTrack record of regulatory interactions and deliverables, e.g., IND, NDA, BLA and MAA filings.In-depth knowledge of current practices and issues in Clinical Pharmacology and Pharmaco-metricsStrong written and oral communication skills necessary to report on and deliver scientific presentations Demonstrated ability to work in a dynamic team-oriented environmentManage a team of CP&P scientists and provide mentorship and guidance to staffIndependently serve lead for one or more assets in the BMS drug development programDemonstrated leadership abilities, expanded sphere of influence, and stakeholder management in a matrix environmentProgramming experience is required (e.g., NONMEM, R, and WinNonlin. SAS, Splus, etc.)Quantitative data analysis, POP PK/PD, and data visualization skills are highly desiredExperience in Radiopharmaceuticals is a plus.

The starting compensation for this job is a range from $200,000 - $237,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided 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 http://careers.bms.com/life-at-bms/

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.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in 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 Protocol

BMS 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 adastaffingsupport@bms.com. 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: https://careers.bms.com/california-residents/

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