Job Description

As Head of Medical Science, you will play a critical role in shaping the scientific vision and medical strategy of our client. Reporting directly to the Chief Medical Officer, you will lead efforts to bridge clinical science and pre-clinical development, ensuring alignment with our mission to deliver transformative therapies to patients. This involves high-level strategic planning as well as significant hands-on responsibilities to support our growing pipeline. Core responsibilities include overseeing the design, oversight, and reporting of clinical trials that meet the highest standards of ethics, scientific merit, and regulatory compliance.

Key Responsibilities

• Manage overall study planning, execution, and delivery of multiple global clinical programs, including oversight of high-quality clinical data collection.
• Review and interpret efficacy and safety data; contribute to clinical trial safety oversight through safety review and analysis.
• Collaborate with Clinical Operations, Toxicology/Pharmacology, Preclinical, Regulatory, Biostatistics, and external contractors to ensure strategic integration of clinical development plans.
• Author, review, and approve clinical study protocols, reports (CSRs), regulatory documents (Investigators Brochures, briefing books, safety updates, IND/CTA submissions), and responses to health authority questions.
• Coordinate with CMC/clinical suppliers on trial supply assumptions and contribute to design and packaging of clinical trial supplies.
• Communicate effectively with internal and external teams through written and verbal channels.

Qualifications

• PhD, PharmD, or MD
• Minimum 10+ years in biopharmaceutical drug development, including early and late-phase clinical studies; CNS/Neuroscience experience preferred.
• Proven leadership of multidisciplinary teams in clinical development across multiple regions.
• Strong strategic and project management skills in drug development.
• Experience working with senior management, KOLs, and regulatory agencies.
• Ability to thrive in a biotech environment, with hands-on leadership and delegation skills.
• Thorough knowledge of FDA, ICH, GCP guidelines, and cross-functional clinical processes.
• Excellent interpersonal, communication, negotiation, and influencing skills.
• Experience managing clinical program accelerations and challenges is desirable.
• Willingness to travel domestically and internationally (up to 10%).

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Job Tags

Hourly pay, Full time, For contractors, Relocation, Work visa,

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