Sanofi Group Senior Director, Group Leader Trial Operations in Bridgewater, New Jersey

The Group Leader (GL) is responsible for managing and overseeing the projects and people in their Therapeutic Area, with respect to international study set up, execution and close-out and to clinical data collection and management. The GL for the Global Medical Affairs portfolio has management responsibility for staff located in Bridgewater NJ and Chilly Mazarin France Clinical Science & Operations (CSO) offices.

The GL will be accountable for the worldwide global execution of clinical programs in the GMA clinical portfolio, in respect to the study timelines, the regulatory and quality requirements and the allocated budgets (both study budgets and departmental budgets). The GL will participate in global harmonization and optimization of processes across Trial Operations groups and be the primary contact for CSO Projects Leaders for discussions on operationalization of the Late Phase / Real World clinical plans, allocated resources, timelines and budgets for new clinical programs implementation. The GL will be one of the CSO Therapeutic area functional leaders, working together to optimize the operational standards for the GMA clinical portfolio.

In this role, the GL will report to the Head of Trial Operations and be a permanent member of the Trial Operations Steering Committee.

The position will build a strong network with the different Sanofi medical offices in the GBUs.

The GL for GMA will have responsibility for over 80 global staff. The GL manages a diverse portfolio of products and a significant number of ongoing small and large complex clinical trials, conducted either in-house with support and input from a wide range of service providers or conducted in full outsourcing models.

Major Duties & Responsibilities

  • Leads deployment of operational excellence for the conduct of clinical programs (in/out sourced). Ensures expedited study start-up with integrated services, develops efficient contingency plans with anticipation to respect performance, quality, costs and timelines

  • Develops and implements optimized strategies and processes. Builds new approaches, processes and standards in ways of conducting clinical trials. Manages their team in developing a high level of team spirit and of motivation and delivery focus approach, maintains and develops operational excellence

  • Defines priorities and goals and follow ups on action items, assists in problem solving and corrective measures and conducts performance appraisals. Ensures training and development of expertise, promotes exchange of best practices and lessons learned.

  • Oversees the global staffing needs and consolidates resource budgets for their group, while taking into account the needs in other TO groups to allow flexibility in staffing management

  • Builds appropriate interfaces with other departments to develop the best trial management model and participates in cross-departmental working groups for process development/optimization. Ensures appropriate circulation of updated information and adequate reporting of implemented actions internally and externally

  • Collaborates with peers in CSO: Medical Operations, Biostats & Programming, Clinical Procurement, Quality, and Project Leaders to deliver the programs in the most efficient way to the highest quality.

  • Responsible for the successful and timely implementation and performance of the operational activities related to the clinical programs attributed to their group. Discusses and validates the operational strategy including allocated resources and timelines and provides input on budgets for clinical program implementation. Analyses and reports on productivity, quality and risk-assessment for projects.

Required Education/Experience

  • Bachelor’s degree and 10+ years of laboratory or medical experience (or equivalent), including 7 + years of clinical research experience in the pharmaceutical industry (or equivalent) is required.

  • Experience in direct and indirect people management in global setting

  • Experience in project and program management in clinical operations

  • At least 4 years of project management experience in clinical operations is required.

  • People effective management skills and leadership

  • Efficient communication and collaboration with project teams, departmental associates, internal and external partners, managers from various disciplines

  • Excellent organizational, interpersonal and communication skills (verbal and written); flexibility, diplomacy, efficient in matrix organisation

  • Project Management skills and ability to oversee several projects simultaneously

  • Ability to work effectively in a global environment

  • Self-motivation, attention to detail while overseeing and connecting with cooperating departments; results driven in terms of timelines and quality

  • Customer & quality focused

  • Experienced with clinical trial management and clinical data management systems and has an adequate level of understanding of database and programming concepts, database structures, file structures; good understanding of current trends in data management technology; thorough understanding of applicable regulations and inspection readiness

  • Competent in International Regulations / Guidelines / Good Practices pertaining to the pharmaceutical industry standards and practices for clinical / epidemiological trials conduct

  • Knowledge about requirements of New Drug Application (NDA)/ Market Authorization Application (MAA) submissions and e-submissions

Preferred Education

  • Advanced Degree

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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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