Bristol Myers Squibb
Director, Clinical Pharmacology and Pharmacometrics
Bristol Myers Squibb, Seattle, Washington, us, 98127
Overview
Director, Clinical Pharmacology and Pharmacometrics — The Director, a member of the Clinical Pharmacology group at BMS, is responsible for ensuring clinical pharmacology support for a portfolio of radiopharmaceutical programs in the oncology therapeutic area. This role includes the creation and implementation of optimized Clinical Pharmacology plans to help advance early development programs through IND / POC, and late-stage development programs through NDA, BLA and MAA and post-approval activities. The Director will play an active role in drug discovery and development efforts to advance RayzeBio's radiopharmaceutical pipeline, with oversight over a critical portfolio and opportunities for growth and development. The location of this opportunity can align to any of our BMS geographic locations including various locations in NJ, Cambridge, MA, San Diego, CA, Brisbane, CA, and Seattle, WA.
Role and responsibilities
Serves as a key member of the CP&P leadership team Responsible and accountable for assigned clinical pharmacology strategy within assigned 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 in concert with pharmacometrics and QSP functional partners Supports strategy for dose selection, dose justification and regulatory filings Reviews and approves relevant scientific data and reports for regulatory filings Develops 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 and execution of clinical pharmacology trials in concert with clinical operations Represents the ClinPharm department on cross-functional disease strategy teams and on relevant governance forums Provides input to Phase 2/3 clinical study design and registrational strategy Supervises the development of the Clinical Pharmacology Plan(s) Supervises design of Clinical Pharmacology studies and manages data analysis, interpretation, and reporting Collaborates 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 authorities May work on key internal initiatives and serves as department representative on relevant external initiatives Builds a team that is 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 working in clinical pharmacology; OR MS 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/group Experienced in applying advanced quantitative analysis and model informed drug development (MIDD) approaches Track 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-metrics Strong written and oral communication skills necessary to report on and deliver scientific presentations Demonstrated ability to work in a dynamic team-oriented environment Manage a team of CP&P scientists and provide mentorship and guidance to staff Independently serve lead for one or more assets in the BMS drug development program Demonstrated leadership abilities, expanded sphere of influence, and stakeholder management in a matrix environment Programming experience is required (e.g., NONMEM, R, and WinNonlin. SAS, Splus, etc.) Quantitative data analysis, POP PK/PD, and data visualization skills are highly desired Experience in Radiopharmaceuticals is a plus.
Compensation and benefits
The starting compensation range(s) for this role are posted above for a full-time employee (FTE) basis. The location-specific ranges include Brisbane/CA/NJ/MA/WA, with additional incentive cash and stock opportunities based on eligibility. Final, individual compensation will be decided based on demonstrated experience. Benefits vary by location and may include medical, dental, vision, wellbeing programs, 401(k), disability and life insurance, paid time off, holidays, parental and caregiver leave, and other perks. For more details, visit the careers site.
Other information
On-site protocol, equal employment opportunity and accommodations information, vaccination guidance, and privacy notices are provided on the careers site. If you require reasonable accommodations in completing this application, contact adastaffingsupport@bms.com. For California residents information, visit the California residents page. All data collected in relation to role applications will be treated in accordance with applicable data privacy policies and regulations.
#J-18808-Ljbffr
Director, Clinical Pharmacology and Pharmacometrics — The Director, a member of the Clinical Pharmacology group at BMS, is responsible for ensuring clinical pharmacology support for a portfolio of radiopharmaceutical programs in the oncology therapeutic area. This role includes the creation and implementation of optimized Clinical Pharmacology plans to help advance early development programs through IND / POC, and late-stage development programs through NDA, BLA and MAA and post-approval activities. The Director will play an active role in drug discovery and development efforts to advance RayzeBio's radiopharmaceutical pipeline, with oversight over a critical portfolio and opportunities for growth and development. The location of this opportunity can align to any of our BMS geographic locations including various locations in NJ, Cambridge, MA, San Diego, CA, Brisbane, CA, and Seattle, WA.
Role and responsibilities
Serves as a key member of the CP&P leadership team Responsible and accountable for assigned clinical pharmacology strategy within assigned 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 in concert with pharmacometrics and QSP functional partners Supports strategy for dose selection, dose justification and regulatory filings Reviews and approves relevant scientific data and reports for regulatory filings Develops 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 and execution of clinical pharmacology trials in concert with clinical operations Represents the ClinPharm department on cross-functional disease strategy teams and on relevant governance forums Provides input to Phase 2/3 clinical study design and registrational strategy Supervises the development of the Clinical Pharmacology Plan(s) Supervises design of Clinical Pharmacology studies and manages data analysis, interpretation, and reporting Collaborates 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 authorities May work on key internal initiatives and serves as department representative on relevant external initiatives Builds a team that is 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 working in clinical pharmacology; OR MS 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/group Experienced in applying advanced quantitative analysis and model informed drug development (MIDD) approaches Track 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-metrics Strong written and oral communication skills necessary to report on and deliver scientific presentations Demonstrated ability to work in a dynamic team-oriented environment Manage a team of CP&P scientists and provide mentorship and guidance to staff Independently serve lead for one or more assets in the BMS drug development program Demonstrated leadership abilities, expanded sphere of influence, and stakeholder management in a matrix environment Programming experience is required (e.g., NONMEM, R, and WinNonlin. SAS, Splus, etc.) Quantitative data analysis, POP PK/PD, and data visualization skills are highly desired Experience in Radiopharmaceuticals is a plus.
Compensation and benefits
The starting compensation range(s) for this role are posted above for a full-time employee (FTE) basis. The location-specific ranges include Brisbane/CA/NJ/MA/WA, with additional incentive cash and stock opportunities based on eligibility. Final, individual compensation will be decided based on demonstrated experience. Benefits vary by location and may include medical, dental, vision, wellbeing programs, 401(k), disability and life insurance, paid time off, holidays, parental and caregiver leave, and other perks. For more details, visit the careers site.
Other information
On-site protocol, equal employment opportunity and accommodations information, vaccination guidance, and privacy notices are provided on the careers site. If you require reasonable accommodations in completing this application, contact adastaffingsupport@bms.com. For California residents information, visit the California residents page. All data collected in relation to role applications will be treated in accordance with applicable data privacy policies and regulations.
#J-18808-Ljbffr