Global Head of Clinical Safety, Development and Marketed Medicines

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The Product Development Safety (PDS) organization delivers patient-centric scientific safety solutions that build trust and create value for society, leading to smarter safety design and decision-making activities throughout the drug lifecycle. PDS sustains Pharmacovigilance (PV) system compliance and quality, in order to foster trust and drive efficiency, while also innovating and improving the capabilities that address the evolving priorities of our enterprise and wider healthcare ecosystem.

We shape clinical safety, risk management approaches, and safety decisions across the entire asset lifecycle-from early development prior to pivotal stage development through to marketed molecules. In close collaboration with cross-functional stakeholders, we drive and implement scientific safety strategies to optimize patient risk management at every stage of molecule maturity. 

The Global Head of Clinical Safety, Development and Marketed Medicines provides global strategic leadership across early development (pre-IND through early clinical phases) and late-stage/marketed assets (pivotal trials through post-loss-of-exclusivity). 

As a core member of the PD Safety Leadership Team, this role shapes Roche’s end-to-end clinical safety and risk management strategies across all therapeutic areas and modalities (medicinal products, devices, ATMPs).

This role leads a team of 9 therapeutic area leaders and oversees an organization of approximately 60 physicians/scientists, who act as the strategic safety leads for all of Roche's development and on-market portfolio. Additionally, the job holder partners closely with the Global Head of Portfolio Clinical Safety, who oversees the safety scientists that support the strategic safety leads, ensuring that the scientific safety needs of all programs are appropriately met.

By taking an 'entire lifecycle view', this role ensures seamless knowledge transfer across phase transitions, drives cross-functional alignment with R&D partners (e.g., gRED, pRED, CICoR, PD), and acts as a key point of escalation for portfolio-level safety decisions and governance (e.g., Drug Safety Committee, Development Boards).

Primary Responsibilities and Accountabilities

Strategic Safety & Portfolio Delivery

• Direct the global strategy for proactive safety and risk management, aligning asset strategies with Target Product Profiles (TPPs) and Clinical Development Plans (CDPs).

• Oversee early-to-late phase safety transitions, optimizing risk minimization strategies, personalized safety approaches, and translational safety inputs.

• Ensure effective representation and input on key governance bodies (e.g., Drug Safety Committee, Translational Safety Committee, Development Boards) and lead safety due diligence for portfolio decisions.

Strategic Partnering & Escalation

• Collaborate closely with PDS peers (e.g., Portfolio Clinical Safety, PV & Scientific Development) and broader R&D groups to drive agile, scientific safety approaches.

• Empower functional experts to lead cross-functional safety initiatives with senior Roche stakeholders and Board chairs.

• Serve as the global point of escalation for critical, complex, or ambiguous portfolio-level safety issues.

Strategic Resourcing & Capability Building

• Partner with PDS leadership to strategically manage capacity, talent deployment, and resource allocation across EDS and LMMS, and Clinical Safety more broadly, based on portfolio priorities.

• Drive capability development initiatives to equip teams with cutting-edge expertise in safety science, pharmacovigilance, data-driven innovations, and strategic influencing.

People Leadership & Culture

• Role model Roche Values and Leadership Commitments, fostering a high-performance, agile, and inclusive global culture across line leaders, scientists, and HCPs.

• Drive transformational change, cross-functional collaboration, and continuous learning, inspiring teams to deliver best-in-class scientific safety research.

• MD (or equivalent) with relevant board certification/eligibility and significant clinical experience (e.g., residency, fellowship, or clinical practice in a recognized specialty/subspecialty) is required.

• Post-graduate qualifications or certifications (e.g., MSc, PhD, or Fellowship in Epidemiology, Pharmacovigilance, Public Health, Clinical Pharmacology, or Toxicology) and/or extensive experience in clinical pharmaceutical research are strongly desired.

• Extensive experience (typically 15+ years) in the biopharmaceutical industry or clinical/medical research environment, with deep domain expertise in development and post-marketing clinical safety.

• Proven track record of senior line and matrix leadership, with demonstrated success in managing high-performing, geographically and culturally diverse organizations through transformational change.

• Direct experience leading clinical safety strategy for complex development programs, supporting medical safety governance, and managing safety issues in ambiguity.

• Thorough understanding of early clinical development, GCP-safety regulations, risk-benefit evaluations, safety due diligence, and global pharmacovigilance standards.

• Outstanding conceptual and strategic thinking skills, with a proven ability to influence senior cross-functional executives with and without authority.

• Proficient in navigating complex, multi-stakeholder matrix environments, building strong collaborative partnerships across organizational boundaries.

• Willingness to travel internationally (>30%) and work across cultures.

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.