Job title : Global Head of Clinical Development - Vaccines

• Location: Swiftwater, PA

About the Job

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Build and maintains detailed knowledge of overall R&D strategy for Sanofi Vaccines and able to articulate the impact / effect this strategy has on Clinical R&D and how Clinical R&D contributes to the broader strategic goals and objectives of Sanofi Vaccines, portfolio, and project evolution.

• Accountable for leading Global Clinical Science in ensuring effective, timely and robust design and management of Sanofi Vaccines’ clinical programs and studies (in support of obtaining regulatory approval), while always ensuring safety, efficacy and appropriate benefit/risk to patients / subjects. Incumbent is responsible for all Clinical sciences activities for vaccine projects globally.

• Coordinates with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Global Clinical Immunology and Global Medical Affairs. Directly manages clinical Sciences research staff involved in Phase I - IV trials and the preparation of associated documents for submission to the appropriate regulatory agencies. Serves as primary contact to clinical sites, the FDA, and the medical community for medical/clinical issues.

• Responsible for ensuring consistent application of standards within Clinical Development globally and work with the global platform heads of Clinical Operations and Medical. Identifies and champions innovative approaches to clinical vaccines development.

• In addition, this position represents the Company within the medical & scientific research community through involvement in international scientific meetings and through professional publications.

• Lead for all platforms within Clinical Operations (Clinical Operations Lead, Global Clinical Study Management, Biostatistics, Data Management, Vaccines Clinical Documentation, Transformation & Performance Office).

• Optimize availability of resources to meet project requirements (contributes to the development of global functional budget and creates and implements functional budgets to meet both project and functional milestones). Provide guidance for problem resolution, working with platform leaders, functional team members and clinical team leaders

Key Accountabilities:

Clinical Sciences

• Provides relevant, functional (Clinical Sciences) input to support the development of the strategy for Clinical R&D; provides specific medical / scientific information towards this end.

• Identifies key stakeholders / interfaces outside of Clinical R&D that impact the ability to deliver on the Clinical R&D strategy.

• Ensures clinical capacity of medical systems to participate in clinical trials in accordance with quality and compliance standards.

• Provides input and expertise to jointly develop a consistent Clinical R&D policy and approach to implementing and monitoring quality and process improvement initiatives.

Strategic Planning Accountabilities

• Builds and maintains detailed knowledge of overall R&D and Franchise strategy for Sanofi-Vaccines and Sanofi- and can articulate the impact / effect this strategy has on Clinical R&D and how Clinical R&D contributes to the broader strategic goals and objectives of Sanofi Vaccines.

• Identifies opportunities, needs, and risks for Clinical Development in driving innovation and delivering new vaccines to the market

• Integrates specific factors that impact the ability to achieve and maximize submissions (e.g., Health Economics, Outcomes Research, regulatory landscape, quality, and compliance standards).

• Sets goals and objectives for Clinical Sciences a) globally b) at respective regional level.

• Systematically and regularly evaluates local, regional, and global initiatives-determines the relative importance and value of each against corporate strategic objectives. Assesses need for medical and clinical infrastructure in markets.

• Applies decision criteria to prioritize regional focus and efforts.

• Builds medical and clinical infrastructure in markets to support execution of clinical R & D programs – engages in strategic relationships with KOLs / MOH / Hospital system

CRSF co-chair (Clinical & Regulatory Strategy Forum)

Implementation Accountabilities

• Accountable for leading the Clinical Sciences organization in ensuring effective, timely and robust design and management of Sanofi Vaccines clinical programs and studies (in support of obtaining regulatory approval), while always ensuring safety, efficacy, and appropriate benefit/risk to patients / subjects.

• Coordinates reviews of statistical interpretation of product efficacy and safety required for regulatory product filings. This includes internal coordination with development, regulatory, medical affairs, and intellectual property/legal functions. External reporting duties include all required clinical trial disclosure and tracking requirements.

• Ensures proactive, timely reporting on progress of clinical programs and trials to clinical R&D management. Monitors progress and performance against strategic objectives and key performance indicators; identifies strengths and development needs that may positively or negatively impact a) the performance of other R&D programs within Clinical R&D and b) Clinical R&D’s ability to deliver against strategic goals.

• Identifies and communicates opportunities and risks for clinical programs and trials; openly raises issues that require input from and discussion with other members of R&D and Clinical R&D leadership.

• In collaboration with other platform Heads of clinical sciences and clinical programs, makes a business case for budget and resource allocation for execution of Clinical R & D plans for various projects globally and within the region; works closely with other functions / platforms to ensure that the budgetary planning process is effective and considers the needs of Clinical R&D overall.

• Supports medical affairs activities by providing regular updates on clinical information for developing products within the various stages of the product pipeline as well as supporting publications and launch activities.

Management

• Manage budget, performance and develops necessary skills and capabilities of team.

• Is responsible for recruitment activities and talent management within the Department.

• People management: setting performance standards and appropriate development plans for staff.

Innovation

• Identifies and champions innovative approaches to clinical vaccines development that will derive greater benefit or value to patients and healthcare providers and potentially reduce risk.

• Identifies and help in the assessment of external business and partnership opportunities including due diligence activities.

• Build and support various discovery programs within the Sanofi Vaccines portfolio.

• Works closely with business development and basic research to identify key contacts that can support technology or assay development that will result in future clinical trial activities. Provides appropriate early clinical feasibility assessments for new targets and support for due diligence reviews of new compounds.

• Develops and maintains an international network of thought leading medical and scientific professionals in key product categories for the purpose of advising on or conducting clinical trials or basic research activities that support the clinical development strategy.

Clinical Operations

• Ensures appropriate training and development of staff within Clinical Operations and ensures the delivery of consistent and high-quality training across skill sets.

• Manages the availability of internal and external resources for NV and MAR projects. Approves resource plans.

• Leads the definition of the clinical operations outsourcing strategy and the relationship management of external providers (CROs) as a chairman of the various EOCs.

• Ensure the establishment and implementation of an overall plan of Quality System support across sites for the delivery of clinical studies that meet highest GCP, Regulatory and Industry standards.

• Design and implement business processes, and tools that optimize resourcing for the execution of clinical studies.

• Monitors trends in the industry environment, e.g., new technologies, and regulations, and works with the heads of platforms to understand the opportunities and threats offered by these developments

About you

Education/Experience

• Medical Degree is required with clinical Sciences experience in the pharmaceutical industry.

• At least ten years responsibility for vaccine clinical development activities through Phase III in the pharmaceutical or biotechnology industries.

• Strong knowledge of biostatistics, vaccine efficacy and safety, and regulatory reporting requirements.

• Excellent presentation and group dynamics skills within a technical audience.

• Expertise in infectious diseases, immunological or epidemiological research.

• Strong leadership skills are necessary. Requires excellent verbal and written communication skills.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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