Vice President of Patient Safety

Vice President of Safety

Hybrid - Boston MA

Competitive Compensation Package Based on Experience

One of SciPro Global's standing partners is looking to make their first Safety hire as their pipeline progresses. Our partner is an exciting Clinical stage Immuno-Oncology biotech located in the Massachusetts area. With impressive Clinical progress across different indications and growth over the last year or so, it's now time to make the key hire of a Head of Safety. This individual will be responsible for leading Strategy for safety, pharmacovigilance, and risk, build and manage the team, and collaborate cross functionally. As safety has been outsourced to this point, you will have the opportunity to bring it in house and develop the department accordingly. Reporting directly into the the SVP of Clinical Development, this role will be integral in the organization.

Responsibilities include (but not limited to):

• Provide Safety expertise for all programs in pipeline both in the IO and ADC space.
• Managing existing PV team member & building the rest of the team.
• Strategically drive Safety forward while ensuring regulatory compliance.
• Lead, author and review clinical safety aggregate reports.
• Leading risk mitigation and risk minimization measures.
• Responding to health authority queries regarding safety & risk sections of regulatory documents.
• Perform signal management & lead signal strategy measures.
• Collaborate cross functionally with clinical development, regulatory, and quality assurance teams.
• Communicate safety updates with external & internal stakeholders.

Requirements include (but not limited to):

• Medical Doctor or Foreign Equivalent.
• Minimum 15 years of Pharmacovigilance & Safety experience at a Biotech or Pharma.
• Experience leading a product through submission.
• Oncology experience required.

Are you looking to join an cutting edge company to help the future of Oncology?

Apply now to begin the process!