Key Responsibilities:
- Develop and execute strategies for clinical pharmacology and pharmacometrics to guide the company's programs through all stages, from research to post-marketing.
- Act as the clinical pharmacology lead on study or project teams, offering expertise in pharmacokinetics (PK)/pharmacodynamics (PD), biopharmaceutics, drug interactions, and quantitative pharmacology.
- Support the progression of small molecules and biologics through critical development stages, including regulatory filings (e.g., IND/CTA, EOP2) and marketing submissions.
- Conduct PK/PD and exposure-response modeling and simulations to support key decisions such as human PK predictions, dose optimization, trial design, risk/benefit evaluations, regulatory submissions, and scientific publications.
- Collaborate closely with cross-functional teams, including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory Affairs, to meet project and corporate goals.
- Partner with internal and external scientific experts to explore new techniques and technologies to maintain cutting-edge pharmacology models and methods.
- Ensure adherence to safety, health, and environmental policies, as well as compliance with GXPs and regulatory standards in clinical pharmacology programs.
Supervisory Responsibilities:
None
Qualifications & Skills:
Education/Experience:
- Ph.D. in Pharmaceutical Sciences or a related field, or equivalent education and experience.
- At least 2 years of relevant experience in drug development.
Experience/Ideal Background:
- Minimum 2 years of post-graduate experience in clinical pharmacology and/or pharmacometrics.
- Experience in the development of small or large molecules.
Knowledge/Skills:
- Strong understanding of clinical and quantitative pharmacology principles.
- Preferred experience with modeling and simulation tools such as NONMEM, R, or similar software.
- Knowledge of regulatory guidelines related to nonclinical and clinical pharmacology for small molecules and biologics.
- Excellent interpersonal, verbal, and written communication skills, with the ability to explain complex technical information clearly.
- Collaborative approach with cross-functional teams.
- Capable of delivering effective presentations and written communications.
- Ability to thrive in a fast-paced environment.
- Familiarity with GLP and GCP regulations.
