Chief Medical Officer, Oncology Clinical Development

Overview

The Senior Director of Global Oncology Clinical Development at Daiichi Sankyo Group sits within a dedicated organization focused on effective clinical trial strategy, design, execution, and interpretation.

This role serves as the primary source of medical accountability and oversight for one or more clinical trials, while also handling matrix management responsibilities across internal and external networks.

Managing Phase 1 through Phase 3 studies, with demonstrated decision-making capabilities, this position provides medical and scientific expertise to cross-functional colleagues.

Responsibilities

• Medical Monitoring:
• Provide medical input regarding country feasibility.
• Consult on decisions related to clinical trial feasibility and contribute to site feasibility assessment from a physician's perspective.
• May provide clinical input into eCRF design, participate in UAT and CCG review.
• Conduct clinical data review per Integrated Data Review Plan.
• Accountable for assessing protocol deviations.
• Discuss medical eligibility questions and answer safety questions (dose modifications, discontinuations, and adverse event management).
• May participate in Site Initiation Visits and conduct medical monitoring visits to provide medical input.
• Provide medical guidance for coding AEs, medical history, and medications when needed.
• Address medical questions directly from sites/IRBs and other site personnel as necessary.
• Study-specific subject matter expert for internal audit or HA questions related to medical monitoring.
• Clinical Development Expertise Strategy:
• In collaboration with the Global Clinical Lead, lead the development and execution of the Clinical Development Plan. Ensure individual protocols are consistent with the CDP and aligned to achieve the Target Product Profile.
• Develop clinical sections of trial-level regulatory documents (e.g., response to HAs, briefing book) in conjunction with Medical Writing.
• Lead scientific components of IM and SIV Training: compound, diagnosis overview, in collaboration with Clinical Scientists.
• Interpret and present clinical study(ies) data to internal and external stakeholders.
• Provide medical/scientific training on compound/disease and dose modifications/discontinuations, as well as adverse event management based on approved Safety Management Team materials.
• Support overall program safety reporting (e.g., PSURs, DSURs, and other safety-related documents) in collaboration with the Safety Physician.
• Maintain up-to-date knowledge of all-important advances within a disease area through scientific literature, critical meetings, and relationships with Key External Experts.
• Contribute to clinical/scientific training of relevant stakeholders on the disease area, competitive landscape, and compound/drug.
• May serve as speaker for program/franchise medical/scientific training in collaboration with the GCL.
• Qualifications
• Successful candidates will meet the qualifications below with or without a reasonable accommodation.
• Education: MD required. Postgraduate training in a related specialty is required.
• Experience Qualifications: At least 7 years of relevant clinical experience is required.
• Travel: Ability to travel up to 20% domestically and internationally is required.