Director, Clinical Pharmacology and Pharmacometrics

Role Summary

The Director, Clinical Pharmacology and Pharmacometrics is a member of the Clinical Pharmacology group at BMS. The role is responsible for providing clinical pharmacology support for a portfolio of radiopharmaceutical programs in the oncology therapeutic area, creating and implementing optimized Clinical Pharmacology plans to advance early development through IND/POC and late-stage programs through NDA/BLA/MAA and post-approval activities. The Director will actively support the RayzeBio radiopharmaceutical pipeline and oversee a critical portfolio with opportunities for growth. Location can align to multiple BMS sites including NJ, Cambridge, MA, San Diego, CA, Brisbane, CA, and Seattle, WA.

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 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 as a 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 collaborative, supportive learning environment

Qualifications

• 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, S-Plus, etc.)
• Quantitative data analysis, POP PK/PD, and data visualization skills are highly desired
• Experience in Radiopharmaceuticals is a plus