Clinical Development Director - Neurology

Job Title: Director, Clinical Development - Neurology
Location: New York or Bosten, US
Job Type: Full-time
About the Company:

We are working with an innovative biotech company dedicated to developing transformative therapies for neurological disorders. With a strong focus on early-stage clinical development, we aim to bring first-in-class and best-in-class therapies to patients suffering from neurodegenerative and neurodevelopmental diseases. Our team is driven by scientific excellence, patient-centric innovation, and a commitment to accelerating drug development in neurology.
Position Summary:

We are seeking a highly motivated Director, Clinical Development - Neurology to lead early-phase clinical programs from First-in-Human (FIH) through proof-of-concept (PoC). Reporting to the Vice President or Chief Medical Officer, the Director will be responsible for designing and executing clinical strategies, overseeing study operations, and ensuring the smooth transition of assets from preclinical to clinical development.

The ideal candidate is a physician-scientist or experienced clinical development leader with a strong background in neurology and early-stage drug development. This role requires strategic thinking, hands-on execution, and the ability to work collaboratively in a fast-paced biotech environment.
Key Responsibilities:
Clinical Development Strategy & Execution

• Lead the clinical development of neurology assets, ensuring alignment with corporate objectives.
• Design and implement clinical trial strategies for Phase 1 and Phase 2 studies, focusing on FIH and biomarker-driven proof-of-concept trials.
• Develop clinical trial protocols, study endpoints, and statistical analysis plans in collaboration with cross-functional teams.
• Analyze and interpret clinical data to guide decision-making on program progression.
• Provide clinical input into regulatory submissions, including INDs, CTAs, and briefing documents for health authority interactions.

Regulatory & External Engagement

• Support regulatory strategy and contribute to interactions with global regulatory authorities (e.g., FDA, EMA).
• Engage with Key Opinion Leaders (KOLs), investigators, and patient advocacy groups to optimize study design and patient recruitment.
• Represent the company at scientific conferences, advisory boards, and investor meetings.

Cross-Functional Collaboration

• Work closely with Translational Medicine, Biomarkers, Clinical Operations, and Regulatory Affairs teams to ensure seamless execution of clinical programs.
• Collaborate with CROs, vendors, and external partners to optimize study timelines and quality.
• Support business development efforts by providing clinical expertise in due diligence activities.

Qualifications & Experience:

• MD, PhD or Board Certification in Neurology, Neuroscience, or a related field.
• 5 years of experience in clinical development, with a strong focus on early-phase neurology programs.
• Expertise in neurodegenerative diseases, neurodevelopmental disorders, or rare neurological conditions is highly preferred.
• Experience designing and executing Phase 1 and 2 clinical trials, including biomarker-driven approaches.
• Strong understanding of regulatory requirements for early-stage neurology drug development.
• Ability to analyze complex clinical data and drive data-driven decision-making.
• Excellent communication, leadership, and collaboration skills.
• Experience in a biotech or small pharma environment is a plus.

#LI-OG1