Sr. Director/Head of Clinical Pharmacology
Sr. Director/Head of Clinical Pharmacology
Location: New York City, NY
Company Overview:
We are partnered with a dynamic clinical-stage biotechnology company focused on developing innovative therapies to address unmet medical needs. They are dedicated to advancing science and improving patient outcomes across several treatments and therapies.
Job Summary:
The Head of Clinical Pharmacology will lead the clinical pharmacology team and oversee all aspects of clinical pharmacology strategy and execution. This role is critical in driving the development of innovative therapies by integrating pharmacokinetic (PK) and pharmacodynamic (PD) principles across multiple clinical development programs. The ideal candidate will have a strong background in clinical pharmacology, excellent leadership skills, and a proven track record in drug development.
Key Responsibilities:
- Lead and manage the clinical pharmacology team, providing mentorship and development opportunities.
- Develop and implement clinical pharmacology strategies to support drug development programs.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure alignment of clinical pharmacology activities with overall project goals.
- Design, oversee, and interpret clinical pharmacology studies, including first-in-human, dose-escalation, drug-drug interaction, and special population studies.
- Ensure high-quality data collection, analysis, and reporting of clinical pharmacology studies.
- Develop and validate pharmacokinetic/pharmacodynamic (PK/PD) models to support dose selection and optimization.
- Prepare and review clinical pharmacology sections of regulatory submissions (e.g., INDs, IMPD, NDAs).
- Foster a culture of continuous improvement within the clinical pharmacology team.
Qualifications:
- Ph.D. or M.D. in Clinical Pharmacology, Pharmacokinetics, or a related field.
- Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, with at least 4 years in a leadership role.
- Strong knowledge of pharmacokinetic and pharmacodynamic principles and modeling techniques.
- Experience with regulatory submissions and interactions with regulatory agencies.
- Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative, cross-functional environment.
- Experience with rare diseases, oncology, or CNS would be a plus.
- Familiarity with modeling software (e.g., NONMEM, R, Phoenix WinNonlin, MATLAB).
- Strong publication record in clinical pharmacology or related fields.
FAQs
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