Clinical Trial Physician

Clinical Trial Physician (CTP), Director Responsibilities: Serve as primary medical accountability/oversight for one or more clinical trials; matrix manage internal/external networks. Manage Phase 1–3 studies (assignment-dependent); provide medical and scientific expertise to cross-functional teams. Design, conduct, and report clinical trials aligned to development/regulatory/global program strategy; lead or contribute to the Clinical Development Plan (CDP) execution from early development through approval. Accountable for protocol concept sheet, final protocol, and protocol amendments. Ensure continuous medical review of aggregated data; act as primary medical contact ensuring protocol adherence and safety oversight. Address medical inquiries from investigators, regulatory agencies, and internal teams; assess key safety-related serious AEs with PVG and oversee narrative. Monitor trial conduct (population, protocol adherence, data trends, AEs/SAEs, emerging safety signals) and lead benefit/risk analysis. Review key documents (e.g., Investigator’s brochure, IND/CTA regulatory documents, integrated development plan sections, submission dossiers); lead medical data review including eligibility criteria. Support Global Clinical Operations for initiation, resource planning, implementation, database lock/interim cuts, site selection, recruitment, and investigator engagement. May lead CDT; may present at investigator meetings/committees; may conduct SIV and medical monitoring visits. Education/Requirements: MD or DO. At least 3 years in pharma/CRO/health science with experience planning/managing clinical trials or deep clinical principles/therapy knowledge. Knowledge of regulatory requirements; experience designing/executing clinical trials. May have performed protocol design academically and/or served as assistant/Principal Investigator; may have been an FDA reviewer. Preferred: Immunology therapeutic area expertise; experience in GI, dermatology, and/or rheumatology. Skills/Competencies: Excellent English scientific communication; manage multiple competing priorities. Strong urgency/time-pressure management; thrive independently. Professional interface with internal/external stakeholders. Travel: ~20% (domestic and international). Hybrid: 2–3 days in Parsippany, NJ or West Chester, PA. Salary range: $231,520–$289,400 annually. Benefits (selected): Comprehensive health insurance; 401(k) match up to 6% and annual 3.75% defined contribution; paid time off; company-paid life/disability; additional listed benefits. #J-18808-Ljbffr Scorpion Therapeutics