Role Summary
The Vice President, Safety and Pharmacovigilance will lead Tangoโs pharmacovigilance and risk management across clinical programs. The role provides strategic direction for Medical Safety Science, manages the Pharmacovigilance team, guides safety strategy, supports global regulatory interactions, and informs portfolio governance and long-term planning. Location: Boston, MA.
Responsibilities
- Lead and oversee all pharmacovigilance and risk management activities for Tangoโs clinical programs
- Develop and execute comprehensive safety science strategies for oncology drug development programs from preclinical through post-market surveillance
- Provide safety expertise and risk-benefit assessments to support go/no-go decisions for oncology programs
- Represent Tango in interactions with health authorities, including preparing and presenting safety data in regulatory meetings
- Provide medical safety expertise and leadership across all clinical development activities, including protocols, CSRs, IBs, ICFs, and regulatory briefing books
- Oversee signal detection, safety surveillance, and benefit-risk assessments, implementing risk mitigation strategies as needed
- Direct the preparation and review of key safety documents, including DSURs, SUSARs, periodic and annual safety reports, and regulatory communications
- Develop and manage PV budgets, ensuring alignment with corporate objectives
- Oversee the development and execution of safety processes, standards, and technologies to improve efficiency, scalability, and scientific quality
- Direct the preparation of safety sections for regulatory submissions including INDs, NDAs, BLAs, and periodic safety reports
- Oversee the development of safety monitoring plans and data safety monitoring boards for clinical trials
- Build and lead a high-performing global safety science organization
- Lead cross-functional safety teams and collaborate with clinical development, regulatory affairs, medical affairs, and commercial teams
- Mentor and develop safety professionals, fostering a culture of scientific rigor and patient focus
- Represent the company at regulatory meetings, scientific conferences, and industry forums
- Collaborate with external partners including CROs, academic institutions, and regulatory consultants
- Champion patient safety as a core organizational value
Qualifications
- MD and 10+ years of experience in pharmacovigilance, safety science, or related roles within the pharmaceutical/biotech industry
- Deep understanding of oncology drug development, including novel therapies (immunotherapy, targeted therapy, cell therapy)
- Strong strategic thinking and business acumen
- Excellent communication skills with ability to present complex safety data to various stakeholders
- Expertise in global pharmacovigilance regulations, safety surveillance, reporting, and risk management strategies
- Experience with regulatory authority interactions, safety database applications, and safety signal detection methodologies
- Strong leadership skills with a proven track record of building and managing safety teams
- Effective communicator with excellent written, verbal, and presentation skills
- Ability to thrive in a fast-paced, high-growth environment, balancing multiple priorities while maintaining a strong commitment to ethical standards