Position Summary
The Associate Director, Clinical Pharmacology drives the implementation, planning, and execution of clinical pharmacology activities across assigned projects with a high degree of independence, partnering collaboratively within the function. Leads trial-level activities and supports development of compounds using strong PK/PD principles and model-based analyses (MIDD) to inform drug development decisions. Works cross-functionally on functional development strategies and mentors the Clinical Pharmacology and Pharmacometrics team.
Key Responsibilities
- Independently contribute to compound development across therapeutic areas (with some supervision)
- Provide input to Phase 2/3 study design and registrational strategy design (with supervision)
- Accountable for the Clinical Pharmacology and Pharmacometrics Plan
- Lead design of Clinical Pharmacology Studies; manage data analysis, interpretation, and reporting
- Apply PK, PK/PD, and MIDD principles and analyses
- Serve as Clinical Pharmacology subject matter expert with cross-functional teams, regulatory submissions, and initiatives
- Participate in health authority interactions as Clinical Pharmacology subject matter expert
- Lead/participate in departmental initiatives; may support external initiatives
- Provide expertise to Business Development teams
Qualifications & Experience
- MS, PhD, or PharmD in a relevant field
- 5+ yearsβ progression in Clinical Pharmacology and Pharmacometrics; experience with the drug development process and small molecule and/or biologic property characterization
- In-depth knowledge of current practices/issues in Clinical Pharmacology and Pharmacometrics
- Strong written/oral communication for scientific presentations
- Demonstrated ability to work in dynamic, team-oriented environments
- Mentorship/guidance experience; supervise staff as needed
- Independently serve as CP&P lead for one or more assets
Preferred/Highly Desired Skills
- Programming experience (e.g., NONMEM, R, WinNonlin, SAS, Splus)
- Quantitative analysis, Pop PK/PD, and data visualization skills
Benefits (as explicitly listed)
- Health coverage (medical, pharmacy, dental, vision)
- Wellbeing support; EAP
- Financial wellbeing/protection (401(k), disability, life insurance, etc.)
- Paid time off and related time-off programs (location-dependent)
Application Instruction
- Apply even if the role doesnβt perfectly match your resume.