Clinical Study Physician

Role Summary

Clinical Trial Physician (CTP), Director, within Clinical Development. Responsible for contributing to the design and implementation of the clinical development plan, collaborating with Disease Area Heads and cross-functional teams, and contributing to regulatory filings and publications. Advanced scientific and clinical knowledge to progress study execution and build relationships with key opinion leaders in the therapeutic area.

Responsibilities

• Serve as the primary medical accountability and oversight for one or more clinical trials
• Matrix management across internal and external networks
• Manage Phase 1‚Äì3 studies (depending on assignment) with decision-making capabilities
• Provide medical and scientific expertise to cross-functional colleagues
• Design, conduct, and report clinical trials in alignment with development, regulatory, and global program strategy
• Contribute to and support the development and execution of the CDP with cross-functional teams
• Be accountable for protocol concept sheets, final protocols, and amendments
• Perform continuous medical review of aggregated data to identify trends and ensure data quality
• Act as the primary medical contact for assigned trials, ensuring safety oversight
• Address medical inquiries from investigators, regulators, and internal teams
• Assess safety-related serious AEs with PVG and oversee narratives
• Monitor trial conduct, data trends, AEs/SAEs, and safety signals
• Review development documents (IB, regulatory documents, IDP/TPP sections, submission dossiers)
• Lead medical data review, including eligibility criteria
• Support Global Clinical Operations in trial initiation, resource planning, and site engagement
• Lead benefit/risk analyses in a matrix environment
• Present at Investigator Meetings and other venues; participate in SIVs or medical monitoring visits as needed
• Maintain TA reputation and expertise; ensure compliance with ICH, GCP, and local laws
• Collaborate with Regulatory, CMC, Biostatistics, GCO; represent Teva at scientific meetings
• Author/review abstracts, posters, manuscripts; engage with external scientific communities

Qualifications

• Education Required: MD or DO; therapeutic area expertise preferred
• Minimum of 3 years in pharmaceutical industry, CRO, or related field with clinical trial planning/management experience
• Knowledge of regulatory requirements governing clinical trials
• Experience in protocol design and execution; PI/IGI experience possible
• FDA reviewer experience for disease area is a plus

Skills

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

Education

• MD or DO required; therapeutic area expertise preferred

Additional Requirements

• Travel approximately 20%, domestic and international
• Role base: Parsippany, NJ or West Chester, PA office