Clinical Study Physician

Role Summary

Clinical Study Physician, Director within Clinical Development, responsible for contributing to the design and implementation of the clinical development plan, collaborating with Disease Area Head, Clinical Development Lead, Clinical Scientist, and other functional areas. Key contributor to regulatory filings and publications; fosters relationships with opinion leaders in the therapeutic area. Advances scientific and clinical knowledge and pro-actively progresses study execution.

Responsibilities

• Serve as a primary source of medical accountability and oversight for one or more clinical trials
• Matrix management responsibilities across the internal and external network
• Manage Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities
• Provide medical and scientific expertise to cross-functional colleagues
• Design, conduct, and report clinical trials in line with development, regulatory and global program strategy
• Contribute to and support the development and execution of the CDP in collaboration with the CDL or DAH
• Accountable for protocol concept sheet, final protocol and protocol amendments
• Ensure continuous medical review of aggregated data during clinical trial conduct
• Serve as the primary medical contact for assigned clinical trials, ensuring protocol adherence and safety oversight
• Address medical inquiries from investigators, regulatory agencies, and internal teams
• Assess key safety-related serious AEs in partnership with PVG and oversee narrative
• Monitor clinical trial conduct, safety data, AEs/SAEs, and emerging safety signals
• Review documents supporting clinical development and submission dossiers
• Lead medical data review of trial data, including eligibility criteria
• Support Global Clinical Operations in trial initiation, resource planning, and site engagement
• Lead benefit/risk analyses for protocols in a matrix environment
• Present at Investigator Meetings and other venues; participate in SIV and medical monitoring visits if needed
• Maintain strong TA expertise and ensure compliance with ICH, GCP, and local laws
• Collaborate with Regulatory Affairs, CMC, Biostatistics, GCO to execute Clinical Development Plans
• Represent the company at scientific meetings, advisory boards, and with regulatory agencies
• Author/review abstracts, posters, manuscripts; engage with external scientific communities to inform internal programs

Qualifications

• Education Required: MD or DO; therapeutic area expertise preferred
• Minimum of 3 years in pharmaceutical industry, CRO, or related health scientific field; experience in planning/managing clinical trials or deep understanding of the area of interest
• Knowledge of regulatory requirements governing clinical trials; experience in design and execution of trials
• Experience with protocol design in academic or investigative settings; may have been FDA reviewer for disease area

Job-Specific Competencies

• Excellent interpersonal, verbal and written scientific communication skills (English)
• Ability to manage multiple priorities and tasks
• Strong sense of urgency and ability to work independently in a fast-paced environment
• Professional interaction with internal/external academicians, agencies, and industry executives in the scientific/medical arena

Education

• MD or DO; therapeutic area expertise preferred