Global Head of Clinical Safety

Job Title
Global Head of Clinical Safety

Location
Barcelona, Spain (hybrid)

Job Description
As the Global Head of Clinical Safety, you will provide medical safety expertise for the benefit/risk assessment of products in clinical development, focusing on biologic Nemolizumab and other assets. You will lead signal detection and risk management activities, oversee safety analyses and reports, review safety‑related information in protocols and submissions, and manage the relationship with key pharmacovigilance partners.

This role has significant autonomy, broad exposure to senior management, and involves leading a global team. Relocation within the EU/UK will be supported for a qualified candidate.

Key Responsibilities

Propose and recommend measures to minimize risks during clinical development; release and update Development Risk Management Plans (DRMPs).

Partner with internal and external stakeholders to monitor safety profiles, validate and evaluate signals, and recommend appropriate risk‑management and minimization measures.

Own aggregate safety reports such as DSUR, PSUR, PBRER.

Own risk‑management plans (RMP) and provide input into safety modules for dossier submission.

Address safety‑related questions from regulatory agencies and stakeholders in dossier submissions.

Contribute to investigator/KOL meetings and Independent Data Monitoring Committee (IDMC) meetings.

Lead safety data review during clinical trials through Safety Plans and safety review meetings.

Escalate and present safety issues at company governance bodies.

Support compliance and PV inspection/audit‑related activities.

Collaborate with Global Regulatory Affairs, Medical Affairs, Clinical Development, Commercial, and other stakeholders.

Line‑manage a team of up to five direct reports.

Skills & Qualifications

Doctor of Medicine (M.D.) required.

12 years of experience in a global clinical safety / pharmacovigilance role in an ethical pharmaceutical company, with an emphasis on drug development.

Minimum 3‑5 years of line‑management experience overseeing Safety Physicians and/or Scientists.

Extensive knowledge of international clinical development and post‑marketing regulations, and biologics best practice.

Experience handling safety medical questions for clinical studies with health authorities in the U.S., EU, and other geographies.

In‑depth knowledge of global pharmacovigilance and safety requirements for non‑clinical and clinical development, registration, and post‑marketing.

Additional degree in clinical pharmacology, pharmacovigilance/drug safety, or epidemiology preferred.

What We Offer In Return

Diverse and inclusive work environment.

Competitive compensation with bonus structure and extended benefits.

Hybrid work culture.

Personalized career development and feedback loops.

Opportunity to grow and take ownership from day one.

This role reports to the Global Head of Pharmacovigilance Risk Management.

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