Sanofi Group Clinical Research Director in Cambridge, Massachusetts
The Clinical Research Director (CRD) provides medical and scientific expertise to the creation and implementation of global clinical development plans and other activities within Sanofi Genzyme related to the corporate mission of developing novel and valued therapeutics for patients with high unmet needs.
The CRD is expected to be a principal team member within the development group. He/she provides medical and scientific leadership in the development of new therapies. The CRD is responsible for the clinical aspects of the Global Clinical Development Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP.
The CRD will become an expert in the disease and experimental therapy for which he/she is responsible. This expertise should be developed and maintained through background medical education, proficiency in current scientific literature, attendance and participation in scientific conferences and relationships with external experts. The CRD will maintain up to date knowledge of practices and scientific literature in the therapeutic area and communicate developments to appropriate internal staff.
The CRD works with the Clinical Science Operation (CSO) team to implement selected clinical trial(s) within the GCDP, including study initiation, study conduct and preparation of study reports.
The CRD leads the Clinical Development Subteam (CDST) working closely with the CSO Project Lead (PL) and is accountable for the development of the clinical development strategy. In this role, the CRD provides clinical input and leadership into the activities of this team in close collaboration with the Global Project Head (GPH) and Project Manager (PM), including the relevant components of the GCDP in accordance with the product profile and corporate goals.
In the creation and implementation of the GCDP, the CRD has a leadership role in partnership with other members of the CDST (i.e., GPH, CSO PL, regulatory, statistics, and PM)
The CRD will lead the preparation of clinical documents/reports for regulatory submission and will attend meetings with regulatory authorities.
The CRD will work in conjunction with the Commercial and Medical Affairs to support the creation of the product value proposition and global product positioning.
In support of licensing and acquisition activities, the CRD will work in concert with business development and provide medical due diligence on opportunities.
The CRD will liaise with the Medical Affairs group to contribute to activities such as review and approval of investigator sponsored studies, contribution to and review of manuscripts that involve Sanofi sponsored studies.
The CRD will liaise with the Research group in the therapeutic area, contributing to the overall science discovery strategy and providing medical assessment of disease and therapeutic targets.
5 + years of pharmaceutical/biotechnology industry or combined industry/ academic experience, with experience in clinical trials.
A working knowledge of GCP.
Specialization in hematology preferred.
Academic experience as a principal investigator a plus.
Strong analytic thinking and the ability to assess scientific data and medical literature.
Excellent written and verbal communication skills. Experience writing abstracts/manuscripts/study reports strongly desired.
Collaborative team work ethic.
Ability to work and lead a matrix team.
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.