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Vice President/Executive Medical Director
4 months ago
Location: Waltham, MA (Hybrid)
Therapeutic Area: Auto-Immune
Job Overview: The role involves strategizing and managing the clinical development of autoimmune drug candidates, necessitating extensive experience in clinical research and a collaborative, fast-paced environment.
Primary Job Responsibilities:
- Lead and take ownership of early stage (phase 1-2) clinical trial design
- Write clinical trial synopsis, protocols, and associated documents
- Collaborate with the clinical operations team to select investigators and provide project-related education to study site personnel and staff
- Plan and oversee all clinical aspects of specific programs
- Lead clinical study teams, monitor trials, and review and analyze safety and efficacy data
- Prepare clinical reports and publications, and present at scientific and medical advisory board meetings and regulatory meetings
Primary Job Requirements:
- MD or MD/PhD with a minimum of 7-10 years of successful experience in Medical Director roles in immunology and inflammation within biotech or pharma industries
- Demonstrated experience in the development of autoimmune drugs to clinical Proof of Concept (PoC) and preferably to the market in the US or EU
- Ability to independently manage a complex clinical research program with minimal direction
- Demonstrated knowledge of clinical trial methodology, regulatory and compliance requirements, and expertise in the development of clinical strategy and the design of study protocols
- Preferred candidates will have significant clinical experience and a strong research background in autoimmune disorders, immunology, or immunotherapy
About Stratacuity:
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PROVEN SCIENTIFIC PLACEMENT™
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