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Tubulis GmbH · 1 day ago

Global Head of Pharmacovigilance and Safety Science

Greater Boston

Full-time

Hybrid

Director/Executive

12+ years exp

Tubulis, Inc. is a clinical stage biotech company that generates uniquely matched antibody-drug conjugates (ADCs) with superior biophysical properties. The Global Head of Pharmacovigilance and Safety Science is responsible for medical, strategic, and operational oversight of drug safety, guiding safety strategy, ensuring compliance, and driving successful trial conduct for Tubulis assets across all stages of development.

BiotechnologyHealth CareLife SciencePharmaceuticalTherapeutics

Hiring Manager

Jennifer Metivier, MS

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

Qualification

Drug safetyPharmacovigilanceOncology experienceLeadershipAntibody Drug ConjugatesGlobal PV regulationsRisk management plansSafety databasesFluency in EnglishCommunication skillsStrategic decision-making

Required

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