At Sanofi CHC, we have one shared purpose - we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centered around people – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Fast Moving Consumer Healthcare Business. We want to be market shapers and achieve category leadership in the categories that we play in - delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example.

As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity.

JOB PURPOSE

The Head of Clinical Operations CHC is a senior leadership role with responsibility for developing and leading the Consumer Health Clinical Operations capability. This includes the development of infrastructure, capability, teams, and program operations to ensure quality, timeliness, and budget for the global clinical studies portfolio. The Head of Clinical Operations is responsible for the development and implementation of high-quality clinical studies, processes and systems including biometry, non-clinical and late phase medical expertise.

KEY RESULTS/ACCOUNTABILITIES

Key Results

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

• Lead and develop a high performing team by developing capabilities and competencies

• Establishing objectives and development goals for the team and developing a pipeline of talent

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

• Build strong leadership capabilities, ensure effective management, and promote professional growth within the team

Accountabilities

• Provide leadership to clinical operations functions across all regions and 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 Consumer Healthcare (CHC) strategy by drawing on their significant Consumer Health and clinical development experience

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

• Ensure adequate resources for clinical operations including overseeing operational plans, tactical execution of studies, protocol preparation and clinical study report writing, etc.

• Establish strong clinical operations and data science capabilities and internal/external partnerships to enable delivery on evidence generation commitments

• Develop specialized capabilities in emerging areas of medical operations – including integration of digital into clinical operations strategies and the leveraging of evidence & real-world approaches

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

• Advise and assist in developing organizational objectives, and plans for their achievement, ensure the set up and monitoring of KPI for clinical operations, identify lead and lag measures with the teams.

• Maintain the overall CHC science hub study portfolio and working directly with the team on an ongoing basis to make sure that studies are coming in and up to date, plan and implement clinical studies within budget, quality and on schedule.

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

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

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

• Provide coaching and development for team members and study specific mentoring as appropriate

KEY WORKING RELATIONSHIPS

• Clinical Operations Quality

• Pharmacovigilance

• Regulatory

• R&D

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Education

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

Required knowledge and/or experience

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

• Over 15 years’ experience in managing global clinical studies, medical scientific affairs, R&D functions and/or regulatory experience in pharmaceutical industry is required.

• 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 is essential

• Significant leadership experience in managing large multi-functional teams is required

• Management of large multi-country budgets is essential

• Experience in building a functional capability from the ground-up highly valued

• Understands the real-world evidence needs, asks the right scientific questions, and dives into complex health datasets (e.g., electronic health records, administrative claims, patient registries) or clinical study data, to inform internal and external stakeholders on the outcome of evidence generation activities.

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

• Experienced in engaging with regulatory authorities for requests / renewals / and Market Authorization Application (MAA) submissions

Language skills

• Fluent spoken and written English

• An Additional language is desirable

Cultural traits : challenge your mindset

• Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment

• Put the interest of the organization ahead of own of those of his/her team: consider both short and long term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level

• Act in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings an external perspective into decisions

• Take action and don’t wait to be told what to do: take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward

• Role model our 4 values: teamwork, integrity, respect, courage

Required Leadership Competencies

• Strategic Thinking - ability to evaluate relevant areas of operation, formulate objectives and set priorities in a contextually relevant way, and develop plans consistent with long-term organizational interests

• Business Acumen – Ability to effectively use economic, financial, market, stakeholder, and industry-specific indicators to fully understand and improve business results

• Judgement- The ability to draw logical conclusions based on acquired information and analytical rigor in problem-solving, the ability to make effective decisions even when information is ambiguous or incomplete

• Team Leadership – Ability to build cohesive, high-performance teams that take accountability and achieve required results

• Interpersonal relationships - treating others with courtesy, sensitivity, and respect.

• Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformation

• Personal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability. Ability to put patient, stakeholder, and organizational interests above personal interests

• Drive -Takes the lead and initiates activities with a high degree of passion and commitment as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence

• Learning Agility – Ability to navigate first time/unfamiliar situations effectively by extrapolating from other areas of expertise and knowledge. Ability to continuously improve and develop self

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.

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, ability or gender identity.

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