Description

The Director, a member of 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.  

 The Director will play an active role in our drug discovery and development efforts to advance RayzeBio’s (a BMS company) radiopharmaceutical pipeline.  This role has oversight over a critical Portfolio and as our Portfolio grows so do 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 (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

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
• 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.