Director, Clinical Pharmacology and Pharmacometrics

Role Summary

The Director, Clinical Pharmacology and Pharmacometrics is a senior leader in the Clinical Pharmacology group responsible for providing clinical pharmacology support for a portfolio of radiopharmaceutical programs in oncology. The role includes creating and implementing optimized Clinical Pharmacology plans to advance early development (IND/POC) and late-stage development (NDA/BLA/MAA) and post-approval activities, with potential involvement in RayzeBio’s radiopharmaceutical pipeline under BMS. Location can align to multiple U.S. sites.

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 partnerships with partner functions and senior leaders
• Oversees scientific output, conduct and resourcing of clinical pharmacology, PK/PD, collaborating with pharmacometrics and QSP 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 delegates support for in-licensing and out-licensing business development activities
• Represents Clinical Pharmacology on governance committees and work streams
• Oversees planning and execution of clinical pharmacology trials with clinical operations
• Represents the ClinPharm department on cross-functional disease strategy teams and governance forums
• Provides input to Phase 2/3 study design and registrational strategy
• Supervises the development of Clinical Pharmacology Plans and study designs, including data analysis and reporting
• Collaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives; serves as a Clinical Pharmacology subject matter expert
• Represents CP&P in interactions with health authorities
• May work on internal initiatives and serve as department representative on external initiatives
• Builds a collaborative, supportive learning environment for the team

Qualifications

• Ph.D. in pharmacokinetics/pharmaceutical science or related field; or PharmD with post-doctoral training; should have 8‚Äì10+ years of clinical pharmacology experience
• OR MS in pharmacokinetics/pharmacology with 12‚Äì15 years of clinical pharmacology experience
• Extensive experience applying clinical pharmacology in early and late-stage drug development
• Experience leading/managing a clinical pharmacology team
• Expertise in quantitative analysis and model-informed drug development (MIDD) approaches
• Track record of regulatory interactions and deliverables (IND, NDA, BLA, MAA filings)
• Strong knowledge of current practices in Clinical Pharmacology and Pharmacometrics
• Excellent written and oral communication skills for scientific reporting and presentations
• Demonstrated ability to work in a dynamic, matrix, cross-functional environment
• Experience mentoring staff and leading CP&P scientists
• Ability to independently lead assets within the drug development program
• Demonstrated leadership, stakeholder management, and influence in a matrix environment
• Programming experience (e.g., NONMEM, R, WinNonlin; SAS, S-Plus, etc.)
• Quantitative data analysis, POP PK/PD, and data visualization skills
• Experience in radiopharmaceuticals is a plus

Skills

• Clinical pharmacology strategy development
• PK/PD modeling and pharmacometrics
• Model-informed drug development (MIDD)
• Regulatory submissions and interactions
• Cross-functional collaboration and stakeholder management
• Leadership and team building
• Data analysis and visualization

Education

• Ph.D. in pharmacokinetics/pharmaceutical science or related field; or PharmD with post-doctoral training; or MS in pharmacokinetics/pharmacology

Additional Requirements

• No specific travel or physical demands specified as essential beyond standard leadership role expectations