Sr. Clinical Trial Physician, Oncology

Role Summary

Sr. Clinical Trial Physician, Oncology — Senior medical accountability and oversight for multiple oncology clinical trials within Clinical Development, leading design, execution, and interpretation of trials.

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
• 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
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Leads collaboration with Clinical Scientist 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 Clinical Scientists to support executional delivery of studies (site activation, enrollment status, and adjudication of deviations)
• Identifies principal investigators and thought leaders to gain inputs on emerging science and study design
• Maintains a strong medical/scientific reputation in the disease area; stays current with etiology, history, diagnosis, and treatment
• Keeps abreast of development and regulatory issues related to competitive compounds and portfolio positioning
• Provides ongoing medical education in partnership with Clinical Scientists for protocol-specific training
• Contributes as medical expert in Health Authority interactions and advisory board meetings
• Authors clinical content for CSRs, regulatory reports, briefing books, and submission documents

Qualifications

• Required: MD or equivalent (US or international)
• Required: 5 or more years of industry and/or clinical trials experience
• Preferred: Subspecialty training in applicable therapeutic area
• Required: Ability to communicate clearly and lead presentations in scientific and clinical settings
• Required: Strong leadership skills and ability to lead in a team environment
• Required: Expertise in drug development process and clinical planning

Education

• MD required (or non-US equivalent)

Additional Requirements

• Travel: Domestic and international travel may be required