Senior Safety Medical Director

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 Position At Roche, we advance science so that we all have more time with the people we love. Our Clinical Safety organisation is dedicated to delivering meaningful improvements to patients through medically-differentiated therapies. In this role, you will provide essential safety science and pharmacovigilance support to molecules across the Roche portfolio, ensuring the highest standards of participant safety and data reliability.

As a Senior Safety Medical Director at Roche, you'll be a recognized expert and strategic leader in drug safety, driving safety strategy for our most complex molecules while building organizational capability across the Clinical Safety organization. You'll provide expert mentorship to colleagues, lead high-stakes regulatory submissions, and represent Roche's safety expertise to regulatory authorities, governance committees, and senior leadership.

This role combines deep technical expertise with strategic influence. This is the perfect opportunity for a safety leader ready to shape the future of drug development and drive organizational excellence. The Opportunity:  Takes the lead in defining, owning, progressing, and guiding the defined safety strategy for their program(s) Accountable for establishing and maintaining the company position on the safety profile and shaping the proactive patient risk communication and risk management strategy.

Must provide an objective and neutral position as a safety professional, even when facing conflicting business priorities or viewpoints. Is the expert content reviewer for safety aspects and must be consulted for safety profile decision-making across the product lifecycle (e.g., updates to the Investigator’s brochure (IB)/safety label, Integrated Safety Management Plan/Risk Management Plan (RMP)).

Leads the development of the safety strategy by providing input into clinical development programs, Target Product Profiles (TPPs), Integrated Evidence Plans (IEPs), health technology assessment (HTA) dossier, and launch strategies. Provides critical safety input to inform decision-making on clinical development plans and individual study designs. Also provides requisite oversight and expert review for safety components of regulatory authority submissions (e.g., IND, NDA, MAA).

Influences key stakeholders (e.g., triad or cross-functional development teams, regulatory leader, medical affairs). Works closely with PCS (Portfolio Clinical Safety) to meet Clinical Safety deliverables and provide medical and scientific interpretation of emerging clinical and nonclinical safety data. Responsibilities due to medical qualifications:  Interpret emerging safety data in the context of clinical medical practice experience and define safety questions/issues requiring specific clinical medical safety assessments.

Perform medical practice impact assessments for product quality safety issues. Determine potential clinical medical impact of non-clinical safety findings and interpret associated product risks. Advise on and interpret how risks may affect the overall clinical risk-benefit balance, considering real-world clinical practice. Make formal company medical assessments regarding the causal relationship between reported events and treatment (e.g., for Individual Case Safety Reports).

Review clinical study plans, protocols, and documentation to ensure appropriate design and feasible risk management measures consistent with current clinical medical practice. Who you are:  You bring a formal medical qualifications (