VP Clinical Development - Boston
Location: Boston or NY, US
Job Type: Full-time
About the Company:
We are working with an innovative biotech company focused on pioneering therapies for neurological disorders. With a strong pipeline of first-in-class and best-in-class assets, we are dedicated to transforming early scientific breakthroughs into life-changing treatments for patients.Our team is driven by a passion for cutting-edge science and a commitment to accelerating drug development in neurology.
Position Summary:
We are seeking an exceptionalVice President, Clinical Development - Neurology to lead the strategic and operational development of our neurology pipeline. Reporting to the Chief Medical Officer (CMO), the VP will oversee the early clinical development of novel therapeutics from First-in-Human (FIH) through proof-of-concept (PoC) studies, ensuring seamless translation from pre-clinical to clinical stages.
The ideal candidate is a physician-scientist or clinical development leader with deep expertise in neurology, neurodegeneration, or neurodevelopmental disorders. This role requires strong leadership, scientific rigor, and the ability to collaborate effectively with cross-functional teams, regulatory authorities, and external partners.
Key Responsibilities: Clinical Development Strategy & Execution- Define and execute the clinical development strategy for neurology programs, ensuring alignment with corporate goals.
- Lead the design and execution of early-phase clinical trials (Phase 1 and 2), including FIH, biomarker-driven studies, and PoC trials.
- Provide medical and scientific leadership to guide clinical trial protocols, study design, endpoints, and regulatory strategy.
- Collaborate closely with Research, Translational Medicine, and Regulatory teams to ensure effective transition from preclinical to clinical development.
- Drive decision-making based on emerging clinical data, ensuring timely Go/No-Go assessments.
- Serve as the primary clinical representative in interactions with global regulatory authorities (e.g., FDA, EMA), contributing to IND/CTA filings and regulatory submissions.
- Develop and maintain strong relationships with Key Opinion Leaders (KOLs), patient advocacy groups, and clinical investigators.
- Represent the company at scientific conferences, advisory boards, and investor meetings.
- Lead and mentor a high-performing clinical development team, fostering a culture of innovation and scientific excellence.
- Work collaboratively with internal stakeholders across functions (e.g., Nonclinical, Biomarkers, CMC, Commercial, Business Development) to drive asset progression.
- Engage with external partners, including academic institutions, contract research organizations (CROs), and industry consortia, to optimize clinical trial execution.
Qualifications & Experience:
- MD, with board certification or PhD in Neurology with extensive clinical development experience in neurology.
- 10+ years of experience in clinical development, with a strong track record in early-phase (Phase 1/2) neurology drug development.
- Expertise in neurodegeneration, neurodevelopmental disorders, or rare neurological diseases is highly preferred.
- Experience leading IND submissions and interactions with global health authorities.
- Strong understanding of translational science, biomarkers, and precision medicine approaches in neurology.
- Proven ability to lead and influence in a biotech or pharma environment, with experience in small, fast-paced organizations.
- Excellent communication and leadership skills, with the ability to engage internal and external stakeholders effectively.
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