A leading biotechnology firm focuses on developing innovative cancer therapies that target specific molecular pathways to improve patient outcomes. Their approach combines cutting-edge research with a deep understanding of cancer biology, advancing treatments that address significant unmet medical needs. With a diverse pipeline of both small molecules and biologics, the company strives to bring forward therapies that can make a meaningful impact on patients' lives. Through collaboration and scientific excellence, they are at the forefront of transforming cancer care with novel, precision-based treatments.
Key Responsibilities
- Develop and execute clinical pharmacology and pharmacometrics strategies to advance Exelixis programs through all stages, from research to post-marketing.
- Serve as the clinical pharmacology lead on project teams, offering expertise in pharmacokinetics (PK)/pharmacodynamics (PD), biopharmaceutics, drug-drug interactions, and quantitative pharmacology.
- Guide the progression of small molecules and biologics through key development milestones, including IND/CTA submissions, EOP2 meetings, and marketing applications.
- Lead or oversee PK/PD and exposure-response analyses using advanced modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions, and publications.
- Collaborate with cross-functional teams, including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory Affairs, to meet project and corporate objectives.
- Drive the visibility of Exelixis' scientific expertise through publications and external collaborations.
- Work with both internal and external scientific experts to evaluate and implement new methodologies, maintaining cutting-edge techniques, models, and capabilities.
- Ensure adherence to SHE policies, GxP compliance, and regulatory standards throughout the clinical pharmacology programs.
Experience
- Minimum of 8 years of experience in clinical pharmacology and pharmacometrics.
- Experience in the development of small molecules, large molecules, and new modalities.
- Experience with the submission of INDs, NDAs, BLAs, and global marketing applications.
- Oncology therapeutic area experience is preferred.
- Contributions to translational science and precision medicine objectives
