Senior Medical Director

Job Description

This job description provides a general overview of the responsibilities and expectations for this role. It is not intended to be an exhaustive list of all duties, skills, or requirements. Additional responsibilities may be assigned as needed to meet business objectives.

Department

Clinical Development / R&D

Job Title

Senior Medical Director

Position Type

Full-Time

Direct Supervisor

SVP, Clinical Development

Supervisory Responsibilities

No

Essential Responsibilities and Duties

• Design study protocols and clinical development plans in collaboration with cross-functional teams both in the US and China, in oncology or autoimmune therapeutic areas.
• Author key clinical sections of IB, IND submissions, regulatory briefing books, Annual Reports, CSR; prepare strategy presentations; present and discuss data with governance, external consultants, KOLs and within regulatory meetings in conjunction with members of the development team.
• Create and/or review study documents/plans including monitoring plan, data management plan, safety review plan, etc.
• Perform ongoing data reviews and assume leadership of safety review meetings.
• Communicate internally and externally both orally and in writing on clinical trial design and results.
• Analyze and synthesize clinical data for publication, conduct and evaluate clinical trials.
• Proactively identify clinical development risks and propose risk mitigation solutions.
• Supervise project team members in planning, conducting, and evaluating clinical trials.
• Serve as medical monitor with significant responsibility for safety surveillance.
• Collaborate with R&D function and senior management in assessing requirements for emerging products, including next generation candidates.
• Identify, select, and train clinical research centers and investigators.
• Oversee planning and management of investigator meetings, advisory boards and other scientific committees as required by the protocol (e.g. independent reviews, DSMB’s etc.).
• Participate in the selection of sites, CROs, and vendors.