Global Head of Pharmacovigilance and Safety Science

Tubulis • Boston, MA

1d • Remote

About The Position

The Global Head of Pharmacovigilance and Safety Science is a strategic leadership role responsible for medical, strategic, and operational oversight of drug safety, guiding safety strategy, ensuring compliance, data interpretation, and driving successful trial conduct for Tubulis assets across all stages of development. This leader will direct safety strategy, operations, and regulatory compliance for oncology drug products across clinical development and commercialization phases. This leadership role is central to ensuring safe, compliant, and successful oncology drug development and to maximizing patient safety and appropriate mitigation strategies from clinical trials to post-marketing surveillance. In addition, the leader will be a key contributor the Development Leadership Team and play an important role in defining and executing the overall product development strategy for Tubulis. This position will report to the Chief Medical Officer within the Clinical Development department and be based in Boston, MA or possible remote opportunities within other locations within the U.S.

Requirements

• Medical Doctor (MD, MBBS, DO) or equivalent clinical degree.
• 12–15+ years in drug safety/pharmacovigilance with at least 5 years at a senior leadership level in biotech and pharma.
• Oncology experience is required.
• In-depth knowledge of global PV regulations and experience with safety and efficacy submissions (IND, BLA, NDA, MAA).
• Experience with risk management plans, signal detection, aggregate safety data review, and case management.
• History of building, leading, and mentoring multidisciplinary teams.
• Familiarity with major safety databases (e.g. Argus), coding dictionaries (MedDRA), and digital safety systems.
• Outstanding communication skills and proven ability to influence, collaborate, and present safety strategy to senior leaders and regulatory authorities.
• Strategic decision-making abilities and the capacity to oversee budgets, resources, and department objectives in a dynamic environment.
• Fluency in English.

Nice To Haves

• Experience with Antibody Drug Conjugates (ADCs) is a strong plus.

Responsibilities

• Develop and execute the overall drug safety and pharmacovigilance (PV) strategy aligned with company and global regulatory requirements, especially for oncology assets.
• Oversee safety surveillance, signal detection, risk assessment, and risk mitigation for investigational and marketed oncology products.
• Select and provide governance for external safety service providers (CROs) to ensure high-quality case handling and reporting.
• Ensure compliance with international PV regulations (FDA, EMA, ICH), SOPs, and best industry practices.
• Lead and build high-performing PV teams, including medical safety experts and regulatory specialists, fostering a collaborative and high-performance culture.
• Provide medical oversight of safety data, including the review of case safety reports (SAEs, SUSARs) and aggregate analyses.
• Lead the identification, evaluation, and management of safety signals using advanced analytics and real-world evidence (RWE).
• Establish and maintain risk management plans, safety monitoring plans, data exchange agreements, and readiness for health authority inspections.
• Represent the company in safety-related interactions with regulatory agencies, partners, external stakeholders and independent Data Safety Monitoring Committees (DSMCs).
• Collaborate cross-functionally with clinical development, clinical operations, data science, regulatory, medical affairs, and other teams integrating safety and optimize benefit-risk profiles across the product lifecycle.

Benefits

• Impact that matters : Contribute to breakthrough therapies.
• Global mindset : Work in an international, diverse team.
• Grow & thrive : Develop your career in a supportive, fast-moving environment.
• Innovation every day : Push boundaries with cutting-edge science.
• At Tubulis, your ideas matter, your growth matters—and together, we make a difference.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree