Head of Medical Science (Bedford, MA)

Cedent Consulting Inc.; Bedford (MA); On-site; USD 150,000 - 250,000; Full time

Job summary

A leading biopharmaceutical consulting firm is seeking a Head of Medical Science to shape scientific vision and medical strategy. This critical role involves overseeing clinical trial operations and collaboration across clinical and regulatory teams to ensure successful product development, while also upholding the highest standards in ethics and compliance.

Qualifications

• 10+ years in biopharmaceutical drug development.
• Experience leading clinical development teams in multiple regions.
• Understanding of FDA, ICH, and GCP guidelines.

Responsibilities

• Oversee management of global clinical programs and study execution.
• Ensure high standards of data collection and regulatory compliance.
• Collaborate with various stakeholders for strategic clinical development.

Skills

Strategic Management

Project Management

Clinical Trial Oversight

Interpersonal Communication

Negotiation Skills

Education

PhD, PharmD, or MD

Job description

About the job
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.

Qualifications:

• 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)

Personal Information

* First name
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* City
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Other Information

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