Global Head of Clinical Safety, Development and Marketed Medicines

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

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 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 Roches 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 Roches 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 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.