Key Responsibilities:
- Lead and contribute to the clinical pharmacology strategy, ensuring alignment with overall development plans and therapeutic goals.
- Design and oversee clinical pharmacology studies, including pharmacokinetics (PK), pharmacodynamics (PD), dose optimization, and biomarker strategies.
- Interpret and analyze clinical pharmacology data, providing actionable insights to inform clinical development, regulatory submissions, and dosing strategies.
- Collaborate with internal teams, including clinical, regulatory, non-clinical, and project management, to drive the development and execution of clinical trials.
- Serve as the clinical pharmacology representative in cross-functional teams and meetings with regulatory agencies, ensuring that clinical pharmacology data supports clinical trial design and regulatory submissions.
- Lead the preparation and review of clinical pharmacology sections of regulatory documents, such as Investigational New Drug (IND) applications, Clinical Study Reports (CSRs), and New Drug Applications (NDAs).
- Stay current with emerging trends in clinical pharmacology, including new methodologies, technologies, and industry best practices.
Qualifications:
- PhD, PharmD, or equivalent degree in pharmacology, pharmaceutical sciences, or a related field.
- Minimum of 7-10 years of experience in clinical pharmacology or a related area within the pharmaceutical or biotechnology industry.
- Strong understanding of pharmacokinetics, pharmacodynamics, and the application of these principles in clinical drug development.
- Proven experience in designing, analyzing, and interpreting clinical pharmacology studies.
- Expertise in regulatory requirements and experience with regulatory submissions (e.g., INDs, NDAs).
- Ability to work effectively in a team-oriented environment and across multiple therapeutic areas.
- Strong communication and interpersonal skills with a demonstrated ability to collaborate with cross-functional teams and external partners.
