This role involves working from the early stages of drug development through to life cycle management, ensuring the integration of quantitative clinical pharmacology principles to optimize drug development and regulatory strategies.
Key Responsibilities:
- Lead the design, execution, and interpretation of quantitative clinical pharmacology studies, including pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response analyses.
- Develop and implement model-based drug development strategies to support dose selection, clinical trial design, and regulatory submissions.
- Collaborate with cross-functional teams, including clinical development, biostatistics, regulatory affairs, and medical affairs, to ensure alignment and integration of quantitative clinical pharmacology activities.
- Provide scientific leadership and mentorship to junior clinical pharmacologists and other team members.
- Represent the company at regulatory meetings, scientific conferences, and in interactions with external stakeholders.
- Contribute to the preparation of clinical pharmacology sections of regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Biologics License Applications (BLA).
- Stay current with advancements in the field of clinical pharmacology and apply innovative approaches to drug development.
Qualifications:
- Ph.D. or Pharm.D. in Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, or a related field.
- A minimum of 8 years of experience in quantitative clinical pharmacology within the pharmaceutical or biotechnology industry.
- Proven track record of leading quantitative clinical pharmacology activities for drug development programs.
- Strong knowledge of pharmacokinetic and pharmacodynamic modeling and simulation techniques.
- Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
- Experience with regulatory submissions and interactions with health authorities.
- Demonstrated ability to think strategically and apply innovative solutions to complex problems.
Preferred Skills:
- Experience with software tools such as NONMEM, R, SAS, or similar for PK/PD modeling and simulation.
- Familiarity with regulatory guidelines and requirements for clinical pharmacology studies.
