Head of Clinical Evidence, Opella

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market. We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet. That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands. This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers. We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification.

Join us on our mission. Health. In your hands.

Job purpose

The Clinical Evidence Head is responsible for leading the strategy and execution of clinical evidence generation to support regulatory approvals, Innovations, and commercial success of Opella products. This role involves designing and overseeing clinical studies to demonstrate product value and safety.

This includes the development of capability, teams, and program operations to ensure quality, timeliness, and budget for the global clinical studies portfolio.

The Head of Clinical Evidence is responsible for a team of experts in Clinical Operations, Statistics and study design.

Main responsibilities

• Set the strategic direction of Clinical Operations & allocate resources to prioritized opportunities

• Develop clinical programs fit-for-Consumer Healthcare, in an agile and innovative manner

• Lead and develop a high performing team by developing capabilities and competencies, and ensure a pipeline of talents

• Foster an environment/culture of learning and sharing of best practice within the team

• Be an active member of the Global Medical & PV Leadership Team

Key activities include:

• Provide leadership across all clinical phases which includes study start up, budgeting, CRO/vendor selection, contracting and training, study closure and study archiving, ensuring compliance with all applicable external regulations (ICH-GCP) and internal quality standards (SOPs / QDs).

• Set the strategic direction and capability of the team, aligning with global and regional needs in-line with the Science Hub and overall Opella Strategy

• Support claims through data generation including conventional clinical studies and emerging digital evidence generation capabilities.

• Oversee operational plans, tactical execution of studies, protocol preparation and clinical study report writing

• Develop specialized capabilities in emerging areas of medical operations – including integration of Digital, Diversity and Sustainability into clinical strategies

• Ensure compliance of key activities to external regulations (ICH-GCP) industry and company quality standards (SOPs / QDs).

• Ensure the set up and monitoring of KPI for clinical operations, identify lead and lag measures with the teams.

• Develop cross-functional collaboration within and amongst research sites, leveraging best practices and learnings to ensure high quality service to customers and patients

• Ensure timely support of authority inspections with regards to quality and regulations.

Key working relationships

Collaborate with Medical, Pharmacovigilance, Regulatory, R&D and Quality team members to ensure strategic fit and compliance of department/study activities with authority (e.g. FDA, EMA) and other regulations, guidelines, and principles of ICH-GCP and company SOPs.

Skills, experience & knowledge requirements

The ideal candidate for the Clinical Evidence Generation Head role is a seasoned professional with extensive experience in clinical research. They possess a strong scientific background, strategic mindset, and leadership skills to drive evidence-based decision-making in support of regulatory approvals, market access, and commercial success.

Education

• Higher level degree (M.D., PhD, MBA) is mandatory.

• Additional certifications in clinical research, regulatory affairs, or health economics are a plus.

Required knowledge and/or experience

• Previous experience leading a global clinical organization including management of large multi-country budgets

• Over 10 years’ experience in managing global clinical studies, medical scientific affairs, R&D functions and/or regulatory experience in pharmaceutical industry .

• A minimum of 10 years of experience in managing global clinical studies including oversight of CROs and study specific vendors

• Experience in a Consumer healthcare product and strategic development environment

• Proficient in International Regulations, Guidelines, Good Practices pertaining to the pharmaceutical industry standard and practices for clinical / bioequivalence studies conduct.

• Experience in regulatory interactions (FDA, EMA, PMDA, etc.) regarding clinical evidence requirements.

Key Skills

• Innovation & Adaptability: Ability to explore emerging data sources, digital tools, and AI-driven analytics for evidence generation.

• Strategic Thinking: Ability to align evidence generation plans with regulatory & commercial needs.

• Scientific Expertise: Deep knowledge of clinical research methodologies, biostatistics

• Regulatory & Compliance Knowledge: Understanding of global regulatory requirements for clinical evidence and post-market surveillance

• Leadership & Communication: Excellent ability to lead multidisciplinary teams, influence decision-making, and present complex data effectively to diverse audiences

• Language skills

• Fluent spoken and written English

• An Additional language is desirable

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com.