Associate Director, Clinical Pharmacology
About The Position
The Associate Director, Clinical Pharmacology conceives, executes, manages, and communicates multidisciplinary clinical pharmacology development plans and strategies to achieve commercial goals and meet regulatory requirements. The role generates and leads new PK/PD study proposals, anticipates and evaluates advances and risks in clinical pharmacology, PK/PD, and regulation, and develops appropriate strategies. It leads clinical pharmacology and PK/PD aspects of multiple projects and critically evaluates technical and scientific aspects in collaboration with Clinical Pharmacology and Pharmacometrics management. The position is accountable for Phase 1–4 study design and clinical pharmacology strategy, and represents projects in cross-functional settings. It leads teams and data analyses, interprets results in the context of research questions, authors regulatory and scientific documents, and represents Clinical Pharmacology in internal, external, and regulatory forums.
Requirements
- PhD with typically 4+ years of relevant experience, or PharmD with typically 6+ years, or a Master’s degree or equivalent education with typically 12+ years, or a Bachelor’s degree or equivalent education with typically 14+ years.
- Relevant experience includes PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, drug metabolism, or transporters.
- Excellent interpersonal skills.
- Ability to interact with internal and external functional representatives and KOLs and to lead teams.
- Strategic thinking and an enterprise view.
- Proven scientific track record and technical skills to perform the role.
Responsibilities
- Develop, execute, manage, and communicate multidisciplinary Clinical Pharmacology development plans and strategies aligned with commercial goals and regulatory requirements.
- Generate proposals for new PK/PD studies and lead those efforts.
- Anticipate and evaluate advances, strengths, weaknesses, opportunities, and threats in Clinical Pharmacology, PK/PD, and regulation, and respond with appropriate strategies.
- Lead Clinical Pharmacology and PK/PD aspects of multiple projects and critically evaluate technical and scientific aspects with Clinical Pharmacology and Pharmacometrics management.
- Take accountability for Phase 1–4 study design and clinical pharmacology strategy, and act as project representative.
- Lead teams and data analyses and interpretation, providing context such as mechanism of action, disease specifics, relevant internal and external data, analysis plans, and model-result interpretation.
- Author regulatory documents, including protocols, study reports, population PK reports, exposure-response analysis reports, CTDs, label sections, relevant investigator brochure sections, and white papers.
- Lead clinical pharmacology and biopharmaceutics meetings; represent Clinical Pharmacology on Clinical Strategy Teams and Asset Development Teams; and present to study teams, the Clinical Pharmacology leadership team, journal clubs, and other cross-functional groups.
- Drive small teams across Clinical Pharmacology functional groups to establish a unified position for clinical, CMC, and regulatory teams.
- Author scientific publications, present at national and international conferences, and interact with KOLs and external stakeholders.
- Conduct due diligence assessments, summarize results, and represent Clinical Pharmacology on business development teams.
- Represent Clinical Pharmacology at regulatory meetings.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
