The Clinical Study Unit (CSU) Region Head, N.A. is responsible for the organization, management and leadership of the CSU countries US and Canada. This position is business critical to reposition the US CSU first-in-class and market competitive with other biopharma operating in US. Criticality is linked to US market potential – ranked #1 commercial market at Sanofi.
This senior leader role will deliver the GROW US Initiative which includes the following ambition –
Increase US patient contribution to 20% of global patients in 2023, >25% beyond 2023
Re-establish US presence in Global Clinical Pivotal Studies: D&I, Pat/ Site Centricity, Operational / Quality Excellence
Establish partnership with US medical, leveraging expertise and networks for KOLs, investigative sites, and diverse populations
Build best-in-class integrated asset management (cross-functional strategy) when communicating in external environment, specifically with sites
Deliver innovation and initiatives for ACT4PT, Global ONE, D&I, etc. as pilots in NAM Region
Attract and retain key local talent, including Site Partnership Manager, Local Study Managers, and Medical Advisors with site networks for Sanofi key TAs
The Clinical Study Unit (CSU) Region Head, N.A. drives and leads all clinical study activity in the North American Cluster and is responsible for ensuring clinical studies are performed according to deadlines, commitment, quality and cost efficiency. S/he ensure that the Cluster countries are aligned to the strategic company priorities and evolution of the business, developing its Cluster strategy aligned to global clinical development and medical plans. The Cluster Head assumes the role of CSU Country Head and its corresponding job description for the country s/he is based in with appropriate management support based on span of control.
Main responsibilities include
Internal and external stakeholder management and representation of the Cluster
Defining and executing strategic roadmaps for: (1) CSU Cluster’s clinical study pipeline, (2) Future of clinical trials including the evolution of the business, (3) Business development with the key Investigators, KOLs and their institutions
Providing clinical development expertise to Medical Affairs to implement global and local post-marketing studies
Integrating medical and scientific intelligence to contribute to the Global Development strategy
Connecting with Patient Associations, according to regulations.
Attracting, developing, and retaining talent
Fostering digital innovation and leading change management in collaboration with medical communities.
Leading and contributing to global CSU and Clinical Sciences & Operations (CSO) workstreams
Optimizing quality, cost efficiency and speed of the clinical studies in the Cluster while ensuring business continuity
Serving as member of Regional CSU Leadership team as well as other relevant teams/focus group
Significant and proven in-depth experience in Clinical Research or related area
In-depth Knowledge of drug development process, clinical trial design, and broad scientific knowledge within a number of Therapeutic Areas
Strategic planning experience, budget management, rigorous priority setting for self and team
Knowledge of North American pharma industry and a solid network
Excellent stakeholder management and influencing skills
Proven ability to inspire and lead large teams through change and transformation to foster innovation and to work well in a transversal and matrixed environment
Ability to manage risk and anticipate change
Data based decision making
Excellent project management skills
Ability to present, influence and interact with C-Suite
Native fluency in English (written and oral)
Advanced scientific degree in science/medicine (MSc, PhD, MD, Pharma)
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.