Sr. Clinical Trial Physician, Oncology

Role Summary

Sr. Clinical Trial Physician, Oncology role within Clinical Development. Responsible for medical accountability and oversight across multiple trials, providing medical and scientific expertise, and guiding development strategies from Phase 1 to Phase 3.

Responsibilities

• Serves as a primary source of medical accountability and oversight for multiple clinical trials
• Matrix management responsibilities across the internal and external network
• Manages Phase 1 - Phase 3 studies, with demonstrated decision making capabilities
• Provides medical and scientific expertise to cross-functional colleagues
• Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT)
• Leads medical data review of trial data, including eligibility review
• Holds responsibility for site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Leads collaboration with CS and inputs into protocols, providing medical strategic oversight in protocol development
• Fulfills GCP and compliance obligations for clinical conduct and maintains required training
• Designs and develops clinical plans and protocols with a strategic focus to meet regulatory and disease strategy targets
• Provides oversight and medical accountability for a group of studies
• Leads benefit/risk analysis for clinical development protocols in a matrix team environment
• Partners with CS to support executional delivery of studies (site activation, enrollment status, adjudication of protocol deviations, etc.)
• Identifies and cultivates principal investigators and thought leaders to inform on emerging science and study design
• Maintains strong medical/scientific reputation in the disease area and stays abreast of literature and regulatory issues
• Provides ongoing medical education with CS to train study teams and investigators
• Contributes to medical expertise in Health Authority interactions and advisory board meetings
• Authors clinical content for CSRs, regulatory reports, briefing books, and submission documents

Qualifications

• MD required (or x-US equivalent)
• 5 or more years of Industry experience and/or clinical trials experience
• Ability to communicate clearly and lead presentations in scientific and clinical settings
• Subspecialty training in applicable therapeutic area desired
• Expertise in the scientific method, including statistical design, analysis, and interpretation
• Expertise in the drug development process
• Expertise in executing effective clinical plans and protocols
• Strong leadership skills and ability to work effectively in a team

Skills

• Medical data review and safety signal assessment
• Protocol development and medical strategic oversight
• Clinical development planning and execution
• Cross-functional collaboration with Clinical Scientists and researchers

Education

• MD required (or x-US equivalent)

Additional Requirements

• Travel: Domestic and International travel may be required