Senior Medical Director

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🕒 March 19

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I-Mab Biopharma

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $65M Post-IPO Equity - I-Mab Biopharma on 2025-07

Biotechnology • Pharmaceuticals

I-Mab Biopharma is a global biotechnology platform company focused on discovering, developing, and commercializing innovative biologic therapies to accelerate patient access to new medicines. The company advances a clinical-stage pipeline of immuno-oncology and other therapeutic biologics—such as bispecific antibodies and monoclonal antibodies—through internal R&D and partnerships, while engaging in investor relations and regulatory activities to support development and commercialization.

📋 Description

• 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.

🎯 Requirements

• 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. • 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 skills • Proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Office Timeline/Project.

🏖️ Benefits

• 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