Position Overview: We are seeking a highly experienced and strategic Senior Director of Drug Metabolism and Pharmacokinetics (DMPK) to lead DMPK department for one of our clients. In this critical role, you will be responsible for overseeing the development and implementation of DMPK strategies that support our drug discovery and development programs.
This role is hybrid in South San Francisco.
Key Responsibilities:
- Project Oversight: Oversee the design, execution, and interpretation of DMPK studies to support drug discovery and development programs. Ensure studies are conducted in accordance with regulatory requirements and industry best practices.
- Cross-Functional Collaboration: Collaborate with internal stakeholders including medicinal chemistry, biology, toxicology, and clinical development teams to integrate DMPK data into drug development plans. Provide strategic input on the optimization of drug candidates based on DMPK findings.
- Regulatory Affairs: Prepare and review regulatory submissions related to DMPK, including INDs and NDAs. Interact with regulatory agencies as needed to address DMPK-related inquiries and ensure compliance.
Qualifications:
- Education: Ph.D. in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or a related field.
- Experience: Minimum of 8 years of experience in DMPK within the biotech or pharmaceutical industry, with at least 5 years in a leadership role. Demonstrated expertise in drug metabolism, pharmacokinetics, and pharmacodynamics.
- Skills: Strong leadership and team management skills. Proven ability to design and oversee complex DMPK studies. Excellent communication and interpersonal skills, with the ability to interact effectively with internal teams and external stakeholders.
- Regulatory Knowledge: In-depth understanding of regulatory requirements and guidelines related to DMPK. Experience with regulatory submissions and interactions with agencies.
