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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 (e.g. MD; MB BS; MB ChB) and have post-graduate experience in one or more areas of clinical medical practice including in medical specialities/disciplines that are relevant to clinical safety and/or to the therapy/disease areas in which the company develops and markets medicines.

• 10+ years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g. academia; CRO; etc); preferably including at least 5 years of experience in a clinical drug safety-related role.

• Demonstrate expert understanding of the scientific aspects of safety, PV and clinical/patient risk management (e.g. via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential.

• Demonstrated ability to lead and influence, with and without authority, in a global matrix environment.

• Excellent written and verbal communication skills and proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.

• Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.

• Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity

• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points and ability to effectively train others on departmental practices and processes

Preferred:

• You hold relevant Board Certification(s) or be board eligible, and/or other relevant post-graduate medical qualifications, in relevant areas of clinical medicine.

Relocation Benefits are not available for this job posting.

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We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

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