Senior Medical Director
I-Mab Biopharma
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
Tech Stack
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical developmentstudy designprotocol writingclinical trial managementdata analysissafety surveillancerisk mitigationclinical research methodologyIND/NDA processoncology
Soft Skills
leadershipcommunicationorganizational skillstime managementinterpersonal skillsself-motivatedattention to detailcollaborationproblem-solvingcross-functional teamwork
Certifications
Medical DegreeGCP certificationICH compliance training