At Hemab you will join a clinical-stage biotech company on an exciting journey to build the ultimate clotting company focusing on high unmet need for patients suffering from neglected bleeding and thrombotic disorders. Based in Cambridge, US and Copenhagen, Denmark, Hemab will offer a great working environment, where we believe that a balanced and varied working life can go hand in hand with high quality drug discovery from idea to market.
We seek an innovative colleague who will challenge conventional thinking about how biotech companies advocate for patients and drive systemic change for underserved communities.
Hemab Therapeutics is seeking an innovative and collaborative leader to serve as Vice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV). Reporting to the Chief Medical Officer, this individual will be responsible for the strategic oversight, execution, and management of Global DS &PV and Risk Management activities across Hemab’s pipeline. The Global Head of DS & PV and will play a key role in collaborating within the DS & PV department and cross functionally to foster a culture of safety, ensure compliance with global safety regulations, and guide Hemab’s safety strategy in collaboration with internal and external stakeholders. This role requires a hands-on leader with robust medical and operational expertise, a strong understanding of global regulatory requirements, and the ability to design and oversee a robust fit-for-purpose safety system that scales with company growth to support excellence in Drug Safety & Pharmacovigilance as a critical part of our mission.
Key Responsibilities:
- Lead and oversee Hemab DS & PV as well as risk management activities for all programs.
- Strategically lead the development of Hemab’s DS & PV department, including operations, compliance and medical functions, based on industry best practices.
- Mentor and develop a high-performing DS & PV team, fostering a culture of safety, compliance, and operational excellence.
- Participate as a core member of Hemab’s senior leadership team, contributing to overall company strategy.
- Develop and manage DS & PV budgets, ensuring alignment with corporate objectives.
- Collaborate cross-functionally with Clinical, Medical Affairs, Regulatory, Quality, Biometrics and other teams to drive safety initiatives.
- Ensure compliance with global pharmacovigilance regulations (FDA, EMA, ICH, EU GVP, and other relevant agencies).
- Manage and oversee internal and external PV resources, including safety functional service providers and consultants.
- Develop processes for and provide safety medical oversight of safety surveillance and benefit risk assessments, including medical review of ICSRs, signal management activities, safety analyses, benefit risk profile development and monitoring, and risk mitigation strategies.
- Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources of product signals.
- Participate in and lead Hemab’s safety governance meetings and, where applicable, data safety monitoring committees.
- Serve as SME author, reviewer, and approver for drug-safety related regulatory submissions (DSUR, BLA, NDA, MAA), clinical study documents (Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), labeling, Company Core Safety Information, etc.) and risk management plans.
- Lead responses to safety questions from regulatory authorities, audits, and inspections while ensuring corrective actions are effectively implemented.
- Represent Hemab in interactions with health authorities, including preparing and presenting safety data in regulatory meetings, and public presentations.
Experience/Education
- MD and 10+ years of experience in drug safety, pharmacovigilance, risk management, or related roles within the pharmaceutical/biotech industry.
- Experience as prior Head of DS & PV, with late-stage clinical development and with BLA/NDA/MAA submissions highly preferred.
- Strong leadership skills with a proven record of building and managing safety teams, including operational and compliance functions.
- Expertise in global PV regulations, safety surveillance, and risk management strategies.
- Experience with regulatory authority interactions and safety signal management.
- Effective communicator with excellent written, verbal, and presentation skills.
- Proactive self-starter with the ability to thrive in a fast-paced, high-growth environment, balancing multiple priorities while maintaining a strong commitment to ethical standards.
- Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration across functions and with consultants and CMOs
Hemab is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
