We are seeking an experienced and highly motivated Director of Clinical Pharmacology to lead our client's clinical pharmacology efforts across multiple therapeutic areas. The successful candidate will be responsible for designing, implementing, and interpreting clinical pharmacology studies to support the development and registration of new therapies. This role requires a deep understanding of pharmacokinetics (PK), pharmacodynamics (PD), modeling and simulation, and regulatory requirements.
Key Responsibilities:
Leadership & Strategy:
- Lead and develop a high-performing clinical pharmacology team.
- Provide strategic input into clinical development plans, ensuring optimal study designs and regulatory strategies.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure alignment on program goals.
Study Design & Execution:
- Oversee the design and execution of clinical pharmacology studies, including first-in-human, dose-ranging, drug-drug interaction, special population, and other necessary studies.
- Ensure the appropriate selection of biomarkers and PK/PD endpoints to inform dose selection and clinical decision-making.
Data Analysis & Interpretation:
- Lead the interpretation of clinical pharmacology data, including PK/PD modeling and simulation.
- Provide expert guidance on the implications of study findings for drug development programs.
- Ensure timely delivery of high-quality clinical pharmacology sections of regulatory documents, including INDs, NDAs, and BLAs.
Regulatory Interaction:
- Serve as the clinical pharmacology representative in meetings with regulatory agencies.
- Provide scientific and strategic input into regulatory submissions, responses to agency queries, and advisory committee presentations.
Innovation & Continuous Improvement:
- Stay abreast of emerging trends and technologies in clinical pharmacology and drug development.
- Implement innovative approaches to enhance the efficiency and effectiveness of clinical pharmacology activities.
Qualifications:
- PhD, PharmD, or MD with specialized training in clinical pharmacology, pharmacokinetics, pharmacodynamics, or a related field.
- A minimum of 10 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry.
- Proven track record of leading clinical pharmacology efforts for drug development programs from early phase through registration.
- Expertise in PK/PD modeling and simulation, and experience with relevant software tools (e.g., NONMEM, WinNonlin).
- Strong knowledge of regulatory requirements and guidelines (FDA, EMA, ICH) related to clinical pharmacology.
- Excellent communication and leadership skills, with the ability to work effectively in cross-functional teams.
- Strong problem-solving abilities and a strategic mindset.
