Head of Medical Science (Bedford, MA)
As Head of Medical Science, you will play a critical role in shaping the scientific vision and medical strategy of our organization. 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 excellence for ethics, scientific merit, and regulatory compliance.
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, PharmD, 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)
Recommended Jobs
R
Client Service Coordinator SUMMARY OF JOB PURPOSE AND FUNCTION The Client Service Coordinator ("CSC") drives the flow of clients and pets through the hospital, maximizes the productivity of the vet…
Inventory & Kitting Specialist
Job Description: Accounting & Inventory Analyst Location: Woburn, MA (On-site) Department: Operations Reports To: Director of Operations Overview Xico Lighting is seeking an experienced…
Facilities Coordinator - Remote
Facilities Coordinator - Remote Job ID 246956 Posted 11-Nov-2025 Service line GWS Segment Role type Full-time Areas of Interest Administrative, Customer Service, Engineering/Maintenance Location(s) Re…
Family Medicine Physician-Mass General Affiliate-seacoast community
One of the largest multi-specialty groups in the Boston, MA area with a medical team of 400 Physicians is actively seeking a Family Medicine provider to add to their group. Practice Features …
Primary Care - Boston / Providence area
Primary Care Physicians Needed in Boston, MA and Providence, RI Areas Join a not for profit independent, community hospital located near both Boston and Providence. Family Medicine – Medical Di…
Senior UVM Digital Verification Engineer
YOU MUST BE A US CITIZEN & MUST HAVE AN ACTIVE SECRET CLEARANCE Our Digital Design Team is seeking a motivated and experienced Senior UVM Digital Verification Engineer to tackle novel verification…
New Construction/Remodel Plumber
Never job search again. Rodenhiser has been crafting an elite team of technicians since 1928 who service thousands of happy customers. With Rodenhiser’s size comes numerous advantages you won’t…
Explore Fall River: Your Next Nursing Adventure Awaits!
Registered Nurse - Emergency Room - Travel - (ER RN) Ready to level up as an ER travel nurse in Fall River? Step into a fast-paced, 12-hour evening Emergency Room role where your RN skills and certif…
Product Manager
Medisafe is looking for an experienced Product Manager to join a dynamic and fast-paced environment and work with cross-functional teams to design programs that deliver the company’s vision and strat…
Customer Support Engineer *MA/Boston/East-Coast Remote...
Join us to help define a new era of operational intelligence. Our dashboards are used by modern IT and engineering teams to turn data into smarter decisions. Our happy customers include major bran…