Head of Medical Science; Boston, MA

Key Responsibilities

• Management of overall study planning, study execution, and delivery of multiple global clinical programs. Including but not limited to oversight of and accountability for the collection of high‑quality clinical data.
• Oversee review and interpretation of efficacy and safety data. Contribution to clinical trial safety oversight by participating in safety review and analysis of clinical trial data consistent with Safety Review Plan.
• Close collaboration with Clinical Operations, Toxicology/Pharmacology, Preclinical, Regulatory, Biostatistics, and outside contractors to ensure the successful strategic integration of clinical development plans and strategies.
• Contribute to authoring, review, and approval of required clinical study protocols, clinical study reports (CSRs), sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/CTA submission documents, and responses to Health Authorities’ questions.
• Collaboration with CMC/clinical suppliers to provide clinical trial supply assumptions and contribution to design and packaging of supplies for clinical trials.
• Communication with internal and external teams in a high impact, highly visible fashion through written and verbal means.

• PhD, Pharm
  
  D, or MD
• Minimum 10+ years of biopharmaceutical industry drug development experience, early through late‑stage development, including the design and conduct of early and late phase clinical studies. CNS/Neuroscience experience strongly preferred.
• Proven ability to lead a multidisciplinary team toward a successful outcome.
• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple geographic regions.
• Excellent strategic and project management skillset with drug development programs
• Ability to work with the Senior Management Team and other external audiences such KOLs and regulatory bodies.
• Ability to thrive in highly entrepreneurial biotech environment, with some prior experience in a small/medium size company an advantage.
• “Hands‑on”, “roll‑up‑the‑sleeves” when necessary, leader who understands the need for involvement in a small company environment while recognizing when to delegate and seek results from the team.
• Thorough understanding of country‑specific, FDA (and equivalent), ICH and GCP guidelines as well as cross‑functional clinical processes including data management, pharmacovigilance, biostatistics, medical writing, and study reporting.
• Excellent interpersonal, communication, negotiation and influencing skills.
• Experience having managed significant accelerations and challenges in clinical programs is desirable.
• Ability to travel domestically and international (up to 10% of the time)