Global Head of Pharmacovigilance and Safety Science

Tubulis GmbH; Boston (MA); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Supportive environment

Career development opportunities

Diverse international team

Job summary

A fast-growing biotech firm in Boston seeks a Global Head of Pharmacovigilance and Safety Science. This executive role involves developing drug safety strategies and ensuring compliance in oncology drug products. The ideal candidate has an MD and extensive experience in drug safety, especially with antibody-drug conjugates. Responsibilities include overseeing safety surveillance, leading teams, and representing the company in regulatory interactions. Join us to innovate in cancer treatment and advance your career.

Qualifications

• 12–15+ years in drug safety/pharmacovigilance with 5 years at senior leadership.
• Experience with Antibody-Drug Conjugates (ADCs) is a plus.
• Fluency in English is mandatory.

Responsibilities

• Develop and execute the drug safety strategy aligned with regulatory requirements.
• Oversee safety surveillance and signal detection.
• Represent the company in safety-related interactions with regulatory agencies.

Skills

Drug safety/pharmacovigilance

Oncology experience

Team leadership

Communication skills

Strategic decision-making

Education

Medical Doctor (MD, MBBS, DO) or equivalent clinical degree

Tools

Safety databases (e.g. Argus)

Coding dictionaries (MedDRA)

Job description

Global Head of Pharmacovigilance and Safety Science

Join to apply for the Global Head of Pharmacovigilance and Safety Science role at Tubulis GmbH.

Take your career to the next level with Tubulis, a clinical stage biotech company that generates uniquely matched antibody‑drug conjugates (ADCs) with superior biophysical properties. We recently closed a Series C round totaling €344 M (US $401 M) to drive the development of novel, effective and safe therapies for the treatment of cancer.

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. The 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.

Your mission

• Develop and execute the overall drug safety and pharmacovigilance 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 optimising benefit‑risk profiles across the product lifecycle.

Your profile

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

Why us?

At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast‑growing biotech where science meets passion—and where you have the chance to grow with us.

• 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.

Seniority level

Executive

Employment type

Full‑time

Job function

Research and Science