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Director / Senior Director: Clinical Pharmacology
3 months ago
The Opportunity:
The Director/Senior Director of Clinical Pharmacology serves as Clinical Pharmacology Lead on core drug development teams. The successful candidate will embrace model-based drug development and lead clinical pharmacology strategy, planning, and delivery for assigned programs and clinical studies. You will play a key role in influencing drug development at Relay Therapeutics by providing both technical and strategic input to program teams and management.
Your Role:
Acts as Clinical Pharmacology Lead on core development teams and sub-teams for assigned Relay development programs. Leads the clinical pharmacology component of integrated development plan. Accountable for clinical pharmacology deliverables to development teams and clinical studies. Leads the strategy to implement model-based drug development using quantitative approaches; Plans and oversees all relevant PK, PK/PD and exposure-response analyses to optimize clinical study dose, dosing regimen and design. Leads clinical pharmacology profiling to support clinical dosing algorithm (e.g. food effect, drug-drug interaction & special populations). Leads clinical pharmacology contributions to regulatory interactions and filings. Conducts clinical pharmacology analyses and oversees vendors who provide clinical pharmacology support to Relay development programs.Your Background:
Advanced degree in pharmacology, pharmaceutical sciences, pharmacy, or other relevant disciplines. Minimum 6-8 years of experiences in clinical pharmacology and/or pharmacometrics supporting drug development, with flexibility in position level for candidates with less or more experiences. Demonstrated experiences in interactions with regulatory authorities and good insight into regulatory guidelines and expectations. Demonstrated team player with strong leadership and influencing skills. Excellent oral and written communication skills. Flexible position level in accordance with qualifications.#JO1
