Director, Clinical Pharmacology and Pharmacometrics

Role Summary

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, incorporating established and innovative approaches, to help advance early development programs through IND / clinical POC, and late stage development programs through NDA, BLA and MAA and post approval activities.

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 (MS) 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, 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

Skills

• Clinical pharmacology expertise
• Model-informed drug development (MIDD)
• PK/PD modeling and pharmacometrics
• Leadership and mentorship
• Cross-functional collaboration
• Regulatory strategy and submissions
• Programming: NONMEM, R, WinNonlin, SAS

Education

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