• 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.
• 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.
• Medical oversight of safety data, including the review of case safety reports (SAEs, SUSARs) and aggregate analyses.
• 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, and external stakeholders.
• Collaborate cross-functionally with clinical development, regulatory, medical affairs, and other teams integrating safety across the product lifecycle.

• 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 (eg 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.