Global Clinical Pharmacology Lead (AD-SD Level)

Global Clinical Pharmacology Lead

Company – A global biopharma who are developing gene therapies, small and large molecules to treat a range of rare diseases.

Location – Massachusetts, Hybrid

About the Role – This role will be part of a global teams and will be responsible for leading the development of strategy for late-stage programs globally and working on early phase studies (pre-clinical and phase I). This is a great opportunity to work on potentially ground-breaking global submissions.

Summary of Key Responsibilities

• Be the Clinical Pharmacology expert of project teams, developing the CP strategy for clinical trials with a particular focus on late and early stage programs.
• Interact with Health authorities being the subject matter expert
• Application of quantitative methods, knowledge of PK-PD, patient characteristics and disease states, to optimize dose regimens and study designs throughout clinical drug development
• Leads study design, execution and reporting of clinical pharmacology/poof-of-concept studies.
• Author/review of clinical pharmacology regulatory submission documents

Education:

• Ph.D, PharmD, or M.D. in pharmacokinetics, biopharmaceutics, clinical pharmacology, pharmacometrics or life science discipline
• Minimum of 5 years experience in clinical pharmacology or pharmacometrics

Why apply?

This is a fantastic opportunity for someone who is looking to develop their career and work on major global major submissions for a global biopharma.

Please submit your resume to us for a private and confidential discussion about the opportunity.