Sanofi Group Head of Clinical Program Lead, Swiftwater, PA in Swiftwater, Pennsylvania

Summary of purpose/major responsibilities

Responsible for leading the Global Clinical Program Leaders organization in driving Clinical operational strategy ensuring effective, timely, high quality and compliant management and delivery of project goals and accountabilities. The team is comprised of a group of professionals in France and the US who are accountable for the franchise/project operational delivery of vaccines studies. Works in close collaboration with the other heads of Clinical Programs platforms, the head of Clinical Sciences, the head of Global Clinical Project Leader (GCPL), the Clinical Franchise leaders, R&D Project Management, and Global Medical Affairs. Represents his/her platform within the global Clinical Programs Leadership Team (CPLT) and other management committees.

Key accountabilities

Strategy

  • Acts as Clinical Programs counterpart to the Clinical Sciences Franchise Leaders to ensure adequate planning of operations within all platforms (resources/budget/planning)

  • Knowledgeable about overall R&D and Franchise strategy for Sanofi-Pasteur; understands the impact / effect this strategy has on Clinical R&D, on Clinical Programs, and communicates to his/her team.

  • Ensures that science is translated into operational strategy.

  • Ensures harmonization of activities (operational strategy) in between studies within a program and transversally, directly or through team members

  • Provides relevant platform input to support the development of the strategy and objectives for Clinical Programs and Clinical Sciences, and defines the global strategy/objectives for his/ her function.

  • Identifies key stakeholders / interfaces outside of Clinical R&D that impact the ability to deliver on the Clinical operational strategy and works with other CPLT members to develop a joint plan for optimal interaction and collaboration (e.g. GMA, Sanofi, and other external partners).

  • Facilitates due diligence.

  • Ensures operational efficiency across programs through investigation and implementation of transversal study efficiencies

Leadership/Management

Leads and manages the global CPL team:

  • Focuses on developing skills and capabilities that support strategic goals and objectives of the organization.

  • Attracts, motivates and retains qualified staff to ensure the attainment of Clinical programs goals and objectives

  • Foster the development of his/her direct reports

  • Coach and mentor team members

  • Ensure training requirements are appropriately followed and tracked at the platform level

Identifies strengths and development needs that may impact:

  • the performance of other functions / platforms within Clinical Sciences / Programs

  • Clinical Sciences / Programs’ ability as a whole to deliver against strategic goals

  • Actively engages in decision-making process with other CPLT and CSLT members, providing input as needed to Head of Global Clinical Programs and Head of Clinical Sciences (as appropriate)

  • Facilitates his/her team’s delivery of adequate operationalization of programs from development to submission and pre-approval inspection (PAI)

Delivery

Represents Clinical Programs at the R&D project level. Makes the link with R&D Project Management for operations.

Creates conditions for successful design and delivery of clinical trials; develops and maintains a program management framework that is financially well managed, compliant, consistent and adaptable to business needs (planning, budgeting, program management, strategic alignment, and influencing of key internal and external stakeholders).

Ensures activities related to his/her global function are conducted with optimum quality and efficiency, meet global regulatory requirements and are in alignment with the overall Clinical Sciences/Programs strategy and priorities.

Monitors his / her platform’s progress and performance against strategic objectives and key performance indicators. Communicates operational opportunities and risks to CPLT and other management committees as appropriate.

Ensures proactive, timely reporting on progress of program management components of clinical trials and communicates program opportunities and risks to CPLT and other management committees; openly raises issues that require input from and discussion with other members of Clinical Management and addresses questions from colleagues.

Ensures delivery at program level of monthly reports and issue escalation.

Ensures clear and timely information is shared between programs, clinical teams, and management

Budget

Ensures appropriate capacity / resource planning and management in conjunction with other functions within Clinical R&D.

Proposes budget and resource allocation for his / her platform; works closely with other functions / platforms to ensure that the budgetary planning process is effective and considers the needs of Clinical Programs overall.

Is accountable for tracking and monitoring of platform budget.

Learning/Continuous Improvement

  • Works with other CPLT members to identify and develop a consistent and integrated approach to implementing and monitoring quality and process improvement initiatives.

  • Champions/Leads those global processes that best address Clinical needs.

  • Ensures that ‘lessons learned’ approach is built into the review and adoption of new approaches and methods.

  • Establishes culture of continuous learning and improvement in his/her platform.

  • Stays abreast of advances in his/her area of expertise.

  • Identifies process issues requiring resolution at the global level and proposes solutions.

Interfaces

Identifies key stakeholders / interfaces outside of Clinical Programs that impact the ability to deliver on the Clinical Sciences / Programs strategy and works with other CPLT members to develop a joint plan for optimal interaction and collaboration (e.g. Clinical Sciences, Medical Affairs, R&D Project Management, Pharmacovigilance, Regulatory Affairs, ITS, Legal, Sanofi CSO, external partners*),

  • not an exhaustive, complete list

Education/experience

Minimum Master's degree with experience in the pharmaceutical industry AND

Extensive experience in clinical research and/or Research & Development;

Knowledge of Vaccine Clinical Development AND

A track record of leadership experience in Clinical or Program development and management

The successful candidate will possess the following competencies:

  • Strategic & Innovative thinking in his/her domain of expertise and beyond

  • Customer/quality focus and results driven

  • Extensive communication expertise; collaboration-oriented

  • Strong people and negotiation skills

  • Entrepreneurial attitude

  • Proactive and ability to drive decision making process

  • Innovative problem solving

  • Strong leadership skills

  • Successfully arbitrate in a complex international, multicultural environment

  • Strong cross cultural awareness

  • Demonstrated ability to drive and facilitate change

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.

#GD-SP

#LI-SP

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life