Sanofi (US)
Overview
Job Title:
Clinical Research Director - RBD Location:
Cambridge, MA Morristown, NJ Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Genzyme Corporation (a Sanofi company) 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. 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. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Responsibilities
The CRD is a principal team member within the development group. Provides medical and scientific leadership in the development of new therapies. Is accountable for the clinical aspects of the Global Clinical Development Plan (GCDP) and for the design, execution, and analyses of clinical trials within the GCDP. Become an expert in the disease and experimental therapy for which the CRD is responsible; maintain up-to-date knowledge through medical education, literature review, conferences, and external expert relationships; communicate developments to internal staff. Work with the Clinical Science Operation (CSO) team to implement selected clinical trials within the GCDP, including study initiation, conduct, and preparation of study reports. Lead the Clinical Development Subteam (CDST) with collaboration from the CSO Project Lead (PL); provide clinical input and leadership into CDST activities in alignment with the Global Project Head (GPH) and Project Manager (PM) and the GCDP components. Lead creation and implementation of the GCDP in partnership with other CDST members (GPH, CSO PL, regulatory, statistics, PM). Lead preparation of clinical documents/reports for regulatory submission and attend meetings with regulatory authorities. Collaborate with Commercial and Medical Affairs to support the product value proposition and global positioning. Support licensing and acquisition activities via medical due diligence on opportunities in partnership with business development. Liaise with the Medical Affairs group to review investigator-sponsored studies and contribute to manuscripts involving Sanofi-sponsored studies. Liaise with the Research group to contribute to the science discovery strategy and provide medical assessment of disease targets. About You
Basic Qualifications:
MD 5+ years of pharmaceutical/biotechnology industry or combined industry/academic experience, with experience in clinical trials A working knowledge of GCP Preferred Qualifications:
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 Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. 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-SA #LI-SA
#LI-Onsite #vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
#J-18808-Ljbffr
Job Title:
Clinical Research Director - RBD Location:
Cambridge, MA Morristown, NJ Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Genzyme Corporation (a Sanofi company) 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. 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. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Responsibilities
The CRD is a principal team member within the development group. Provides medical and scientific leadership in the development of new therapies. Is accountable for the clinical aspects of the Global Clinical Development Plan (GCDP) and for the design, execution, and analyses of clinical trials within the GCDP. Become an expert in the disease and experimental therapy for which the CRD is responsible; maintain up-to-date knowledge through medical education, literature review, conferences, and external expert relationships; communicate developments to internal staff. Work with the Clinical Science Operation (CSO) team to implement selected clinical trials within the GCDP, including study initiation, conduct, and preparation of study reports. Lead the Clinical Development Subteam (CDST) with collaboration from the CSO Project Lead (PL); provide clinical input and leadership into CDST activities in alignment with the Global Project Head (GPH) and Project Manager (PM) and the GCDP components. Lead creation and implementation of the GCDP in partnership with other CDST members (GPH, CSO PL, regulatory, statistics, PM). Lead preparation of clinical documents/reports for regulatory submission and attend meetings with regulatory authorities. Collaborate with Commercial and Medical Affairs to support the product value proposition and global positioning. Support licensing and acquisition activities via medical due diligence on opportunities in partnership with business development. Liaise with the Medical Affairs group to review investigator-sponsored studies and contribute to manuscripts involving Sanofi-sponsored studies. Liaise with the Research group to contribute to the science discovery strategy and provide medical assessment of disease targets. About You
Basic Qualifications:
MD 5+ years of pharmaceutical/biotechnology industry or combined industry/academic experience, with experience in clinical trials A working knowledge of GCP Preferred Qualifications:
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 Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. 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-SA #LI-SA
#LI-Onsite #vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
#J-18808-Ljbffr