Bristol Myers Squibb
Director, Clinical Pharmacology and Pharmacometrics
Bristol Myers Squibb, Brisbane, California, United States, 94005
Director, Clinical Pharmacology and Pharmacometrics
The Director, a member of the Clinical Pharmacology group at Bristol Myers Squibb, is responsible for ensuring clinical pharmacology support for a portfolio of radiopharmaceutical programs in oncology.
This role includes the creation and implementation of optimized clinical pharmacology plans to advance early development programs through IND/clinical POC, and late‑stage programs through NDA, BLA, MAA, and post‑approval activities. The Director will play an active role in drug discovery and development efforts to advance RayzeBio’s radiopharmaceutical pipeline.
Location Flexible across BMS geographic locations including NJ, Cambridge (MA), San Diego (CA), Brisbane (CA), Seattle (WA), and others.
Role and Responsibilities
Serves as a key member of the CP&P leadership team
Responsible for assigned clinical pharmacology strategy within projects
Contributes to integrated strategy with Research, Drug Development, and Commercialization
Develops and executes clinical PK, PK/PD, pharmacometric analyses, and modeling & simulation plans
Drives decision‑making and strategy over the entire portfolio through effective partnership with partner functions and senior leaders
Oversees scientific output, conduct and resourcing of clinical pharmacology, PK/PD, working with pharmacometrics and QSP partners
Supports dose selection, justification, and regulatory filings
Reviews and approves relevant scientific data and reports for regulatory filings
Develops technical/leadership skills of clinical and M&S 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 and execution of clinical pharmacology trials with clinical operations
Provides input to Phase 2/3 clinical study design and regulatory strategy
Supervises the development of the Clinical Pharmacology Plan(s)
Manages design of clinical pharmacology studies, data analysis, interpretation, and reporting
Serves as a subject‑matter expert in interactions with health authorities
Builds a collaborative, supportive learning environment
Requirements
Ph.D. in pharmacokinetics/pharmaceutical science or relevant field; OR
PharmD with post‑doctoral training; Ph.D. and PharmD should have at least 8‑10+ years experience in clinical pharmacology; OR
MS in pharmacokinetics/pharmacology or relevant field with 12‑15 years experience in clinical pharmacology
Extensive expertise in application of clinical pharmacology in early and late stage drug development
Experience leading/managing a clinical pharmacology team/group
Experienced in advanced quantitative analysis and model‑informed drug development approaches
Track record of regulatory interactions and deliverables (IND, NDA, BLA, MAA filings)
In‑depth knowledge of current practices and issues in Clinical Pharmacology and Pharmacometrics
Strong written and oral communication skills for scientific presentations
Ability to work in a dynamic team‑oriented environment
Experience managing a team of CP&P scientists and providing mentorship
Independent lead for one or more assets in BMS drug development program
Demonstrated leadership, expanded influence, and stakeholder management in a matrix environment
Programming experience in NONMEM, R, WinNonlin, SAS, Splus
Quantitative data analysis, POP PK/PD, and data visualization skills highly desired
Experience in radiopharmaceuticals is a plus
Compensation Overview Brooklyn – CA – 226,130–274,021 Cambridge – 226,130–274,021 Princeton – NJ – 201,910–244,666 San Diego – RayzeBio – CA – 218,060–264,236 Seattle – 1000 Dexter – WA – 218,060–264,236
Benefits Medical, pharmacy, dental, and vision care; wellbeing support; financial wellness resources; 401(K); life insurance; disability; family leave; and more. For complete details, visit https://careers.bms.com/life-at-bms.
Equal Employment Opportunity BMS is committed to equal opportunity. For additional EEO information, visit https://careers.bms.com/eeo-accessibility.
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This role includes the creation and implementation of optimized clinical pharmacology plans to advance early development programs through IND/clinical POC, and late‑stage programs through NDA, BLA, MAA, and post‑approval activities. The Director will play an active role in drug discovery and development efforts to advance RayzeBio’s radiopharmaceutical pipeline.
Location Flexible across BMS geographic locations including NJ, Cambridge (MA), San Diego (CA), Brisbane (CA), Seattle (WA), and others.
Role and Responsibilities
Serves as a key member of the CP&P leadership team
Responsible for assigned clinical pharmacology strategy within projects
Contributes to integrated strategy with Research, Drug Development, and Commercialization
Develops and executes clinical PK, PK/PD, pharmacometric analyses, and modeling & simulation plans
Drives decision‑making and strategy over the entire portfolio through effective partnership with partner functions and senior leaders
Oversees scientific output, conduct and resourcing of clinical pharmacology, PK/PD, working with pharmacometrics and QSP partners
Supports dose selection, justification, and regulatory filings
Reviews and approves relevant scientific data and reports for regulatory filings
Develops technical/leadership skills of clinical and M&S 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 and execution of clinical pharmacology trials with clinical operations
Provides input to Phase 2/3 clinical study design and regulatory strategy
Supervises the development of the Clinical Pharmacology Plan(s)
Manages design of clinical pharmacology studies, data analysis, interpretation, and reporting
Serves as a subject‑matter expert in interactions with health authorities
Builds a collaborative, supportive learning environment
Requirements
Ph.D. in pharmacokinetics/pharmaceutical science or relevant field; OR
PharmD with post‑doctoral training; Ph.D. and PharmD should have at least 8‑10+ years experience in clinical pharmacology; OR
MS in pharmacokinetics/pharmacology or relevant field with 12‑15 years experience in clinical pharmacology
Extensive expertise in application of clinical pharmacology in early and late stage drug development
Experience leading/managing a clinical pharmacology team/group
Experienced in advanced quantitative analysis and model‑informed drug development approaches
Track record of regulatory interactions and deliverables (IND, NDA, BLA, MAA filings)
In‑depth knowledge of current practices and issues in Clinical Pharmacology and Pharmacometrics
Strong written and oral communication skills for scientific presentations
Ability to work in a dynamic team‑oriented environment
Experience managing a team of CP&P scientists and providing mentorship
Independent lead for one or more assets in BMS drug development program
Demonstrated leadership, expanded influence, and stakeholder management in a matrix environment
Programming experience in NONMEM, R, WinNonlin, SAS, Splus
Quantitative data analysis, POP PK/PD, and data visualization skills highly desired
Experience in radiopharmaceuticals is a plus
Compensation Overview Brooklyn – CA – 226,130–274,021 Cambridge – 226,130–274,021 Princeton – NJ – 201,910–244,666 San Diego – RayzeBio – CA – 218,060–264,236 Seattle – 1000 Dexter – WA – 218,060–264,236
Benefits Medical, pharmacy, dental, and vision care; wellbeing support; financial wellness resources; 401(K); life insurance; disability; family leave; and more. For complete details, visit https://careers.bms.com/life-at-bms.
Equal Employment Opportunity BMS is committed to equal opportunity. For additional EEO information, visit https://careers.bms.com/eeo-accessibility.
#J-18808-Ljbffr