Medical Director, Oncology Clinical Development

Role Summary

Medical Director, Oncology Clinical Development. Responsible for clinical research activities advancing the development of the portfolio and engaging in medical dialogues with scientific and medical leaders to lead clinical data generation activities, and for managing relationships with Key External Experts. Requires a physician capable of developing and executing oncology clinical trials to support regulatory filings and initial market launch of oncology agents.

Responsibilities

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Ensure high quality protocol development aligned with the Clinical Development Plan to determine a medicine’s potential efficacy, safety profile, key areas of differentiation and value to patient in the shortest possible timeframe
• Contribute to end-to-end development to ensure scientific integrity and timely delivery of clinical trials aligned with regulatory approvals, lifecycle management, and global decision making
• Interpret and summarize study results to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient-reported outcomes for the targeted population
• Assume medical responsibility for clinical trials with real-time medical monitoring, including patient eligibility, study design questions, and urgent safety issues (with Safety/ PV as relevant)
• Medical review of clinical trial data, including oversight of delegated medical review and blinded data review for IDMCs
• Review/monitor safety data in collaboration with pharmacovigilance for active studies
• Participate in authoring clinical study reports and regulatory documents; collaborate with Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to inquiries
• Collaborate with Principal Investigators on evaluating publications (abstracts, posters, manuscripts) linked to clinical data
• Network to develop long-term strategic partnerships with thought leaders internally and externally
• Understand biological mechanisms, clinical strategy, and interpretation of disease and target-based literature
• Serve as a core member of the Clinical Matrix Team for one or more assets in development
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams
• Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate

Qualifications

• Medical degree with completion of post-medical education clinical residency training
• Board/registration qualifications in medical oncology, hematology, pathology or internal medicine
• Oncology experience in pharmaceutical/biotechnology industry and clinical practice experience in the fields noted above
• Documented academic and/or clinical research publication history or history of medical practice in the fields noted above
• Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials and publications
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

Preferred Qualifications

• Board/registration certified or eligible physician with a PhD degree
• Experience in leading oncology clinical trials, including study design, data review/interpretation and the overall clinical development process
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution

Education

• Medical degree and post-graduate training; board/registration in relevant oncology/related field