Global Clinical Development Strategy Expert
This role in the mRNA and Translational Medicine Franchise will be expected to provide clinical and R&D expertise, guidance and direction in the context of experimental medicine and early development for developing mRNA vaccines. This role would be leading clinical and translational studies to optimize the mRNA platform including understanding mechanism of action. The role would be expected to lead one or more clinical trials and/or programs.
The Global Clinical Development Strategy Expert (GCDSE) provides scientific and clinical leadership in the design and development of clinical studies and programs for Sanofi Vaccines R&D. They have global responsibility and ownership for the Clinical Strategy, the respective Clinical Development Plans (CDP) and study protocols for projects / programs and ensure that CDPs are written in accordance with the Target Product Profile, IEGP and according to Franchise and Global Project Team strategy. The GCDSE will assure global consistency across regions. The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate.
As the leader of the Clinical (or Extended Clinical) Team, the GCDSE is the clinical representative in global project teams (GPT). The GCDSE is a subject matter expert in the disease area of the programs covered. The GCDSE is accountable for and leads the discussion of CDP and relevant study documents including protocol and results with regulatory authorities, other external bodies such as Independent Data Monitoring committees and Advisory Boards; the GCDSE supports other GCDSE colleagues elsewhere for such interactions with similar bodies, if this responsibility is delegated, while assuring global consistency. The GCDSE is also responsible for country / regional / global interactions with regulatory and public health agencies, governments and supranational non-governmental organizations, key opinion leaders and investigators as required. They also collaborate closely with regional R&D, global medical affairs, and country managers. As such, they have global responsibility and ownership for clinical sections of the Common Technical Document (CTD) as well as for interactions with Regulatory Affairs for pre-submission and submission meetings with Agencies.
The GCDSE establishes the conditions essential for determining the safety of all subjects involved in Clinical trials for the vaccine development candidates they oversee. They are also accountable for the ethical integrity of clinical plans, adherence to the highest ethical standards of Clinical trial conduct and adherence to all GCP requirements concerning human subjects. The GCDSE will execute the CDP as close as possible to company optimized timelines. The GCDSE performs medical monitoring activities for studies within the country, region or on a global level as appropriate, addressing any medical questions the site investigative teams have regarding clinical protocols, and monitors study conduct in close collaboration with study management & logistics and Global Pharmacovigilance.
Interfacing between Development Sciences and Operations:
The GCDSE is the clinical/medical/scientific expert who supports the translation of a target product profile into a feasible CDP, taking into account scientific environment, resource possibilities, clinical feasibility and timely execution. This requires a good understanding of the possibilities and limitations of the operational environment, team leadership skills, communication skills, knowledge of the therapeutic area, ability to understand business needs and how to translate them into feasible operational plans.
The GCDSE leads the clinical study team and as such requires leadership skills, communications skills, ability to operate in multidisciplinary and multi-cultural teams, ability to inspire teams.
- Physician, with training in Pediatrics or Internal Medicine in addition to training or experience in immunology or infectious diseases, preferred. MD, PhD or PharmD is a minimum scientific qualification.
- 5-10 years Pharmaceutical industry experience preferred, with exposure to diverse array of programs in early and late-stage development or
- 5-10 years or more experience conducting early and late-stage clinical trials in an academic environment
- Demonstrated scientific productivity (publications, research reports, etc.) and ability to critically review/interpret research data, preferred.
- Demonstrated planning, organizational skills, interpersonal, problem solving and excellent written and verbal communication skills.
- Ability to work independently across many interfaces and platforms in a matrix, cross-cultural environment is essential.
- Written and oral fluency in English required
- M.D. or PhD completion of an approved residency training program in a related field or equivalent is preferred.
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.