Senior Medical Director in Rockville, Maryland at I Mab Biopharma US Limited

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.

Qualifications and Skills

Education and Experience:

• Medical Degree from an accredited Medical School required
• 2-5 years of experience within a pharmaceutical company environment preferred.
• Working knowledge of medical, scientific, and clinical research in the oncology and autoimmune therapeutic areas highly preferred.

Required Skills and Abilities:

• Extensive direct knowledge of the clinical development process with the ability to understand concepts of various phases and principles of study design is required
• Experience interacting with medical monitors, development operations and clinical investigators
• Thorough understanding of ICH, GCP, and relevant regulatory requirements is required.
• A thorough understanding of clinical research methodology including study design, protocol writing and CRF preparation is required as is a knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA process acquired through direct industrial experience is required
• Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area.
• The ability to work with cross-functional teams in a matrix environment is a must
• Strong organizational and time management skills; meticulous and detailed oriented
• Self-motivated and able to work with limited supervision
• Excellent interpersonal and communication skillsProficiency with Microsoft Outlook, Excel, Word, PowerPoint and Office Timeline/Project.

Other:

• Ability travel domestically/globally at relevant oncology medical meetings/conferences (i.e., ASCO, SITC, ASH, etc.) up to 15 - 20% of the time
• Authorized to work in the United States without Visa sponsorship

Work Environment & Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Occasional standing, walking, and reaching within the office environment
• Ability to lift up to 15 pounds at times
• Ability to perform essential job functions with or without reasonable accommodation