Description

You will lead the clinical pharmacology strategy across all development programs, including late-stage registrational efforts and early-phase assets. Your work will guide dose optimization, exposure-response modeling, regulatory strategy, and NDA submission components to address the needs of patients with cancer.

Requirements

• Ph.D., Pharm.D., or M.D. in Clinical Pharmacology, Pharmacokinetics, or related discipline
• 12+ years of clinical pharmacology experience in biopharma, including oncology leadership
• Proven track record supporting registrational-stage programs and regulatory submissions
• Experience with kinase inhibitors and oncology therapies strongly preferred
• Familiarity with late-phase trial design and commercial launch preparation

Responsibilities

• Develop and execute clinical pharmacology strategies for Phase 1, registrational, and post-marketing studies
• Integrate PK, PD, safety, and efficacy data for dose selection and labeling recommendations
• Lead clinical pharmacology contributions to INDs, CTAs, IBs, and NDAs
• Represent clinical pharmacology in FDA and global regulatory interactions
• Oversee population PK, PK/PD modeling, and exposure-response analyses