Medical Safety Director

Hybrid - Cambridge, MA

Competitive Compensation Package Based on Experience

$270,000 - $300,000 + Annual Bonus + Stocks

SciPro Global is exclusively partnered with a Stable & steadily growing biotech that is doing incredible work with a pipeline across the Immunology and Oncology space. As their pipeline progresses, there are positions opening up in their Safety group. This group is solution oriented and full of team players, while being led by a direct, passionate, and impressive leader in the US. This position will report directly into the Senior Director Pharmacovigilance & Safety and provides unlimited career growth & stability with the technology that they are working on.

Responsibilities include (but not limited to):

• Safety analysis of both clinical trials & post marketed products.
• Leading clinical safety aggregate reports such as PADERS.
• Leading risk mitigation and risk minimization measures for global studies, specifically working with RMPs.
• Responding to health authority queries regarding safety & risk sections of regulatory documents.
• Perform signal management & lead signal strategy measures.
• Safety surveillance of all assigned products.
• Cross functionally act as Safety SME for assigned products & liaise with other Clinical counterparts across the organization.
• Communicate safety updates with external & internal stakeholders.
• Provide safety input for clinical study design activities.
• Identify ways of improvement for team & safety group.

Requirements include (but not limited to):

• Medical Director or Foreign Equivalent.
• Minimum 4 years of Safety experience working at a biotech or pharma.
• Strong signal detection experience required.
• Experience as safety lead for investigator brochures.
• Phase 1 Safety review experience.
• Solution Oriented mindset & motivated!

Are you looking to join an exciting company to grow your career?

Apply now to begin the process!