Sanofi Group Clinical Research Director, Rare Diseases in Cambridge, Massachusetts
The Clinical Research Director (CRD) provides medical and scientific expertise on the development of the medical strategy for the clinical development, creation and implementation of the global clinical development plans of therapies for Niemann-Pick Disease Type A and B (also known as ASMD) in Rare Diseases Clinical Development at Sanofi.
The CRD is a principal team member within the development group. (S)he provides medical and scientific leadership in the development of new therapies. The CRD is responsible for the medical aspects of the Global Clinical Development Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP. (S)he will work with a team composed of clinical development experts, statisticians, clinical operations personnel, medical writers, safety experts, regulatory affairs and external thought leaders to elaborate the best studies to show safety and efficacy, ultimately to obtain approval around the globe.
(S)he 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. (S)he will maintain up to date knowledge of practices and scientific literature in the therapeutic area and communicate developments to appropriate internal staff.
S(he) will act as an internal consultant/expert working closely with Medical Affairs, Business Development, Regulatory and Science organizations and may perform medical due diligence for external opportunities. (S)he will also support training on the disease to various internal stakeholders and present at internal governance and other meetings as well as external scientific meetings.
(S)he will present at regulatory meetings in various geographies to support the agreed-upon plan, and oversee the Medical Monitors responsible for monitoring clinical trials. (S)he will assist in regulatory activities including:
A. Development of a working knowledge of regulatory aspects of the drug approval process including drugs, biologics, devices, as applicable
B. Development of the regulatory strategy for the product consistent with the GCDP (orphan designation, use of surrogate endpoints, fast track designation, number and types of clinical trials, etc)
C. Contributions to regulatory documents (INDs, NDAs, BLA’sMAAs, IDEs. Annual reports) and other written communications to regulatory bodies
D. Preparation and participation in meetings with FDA, EMA and other regulatory authorities
The candidate will also contribute their medical expertise in drug development to other project teams. Specifically, s(he) will be a member of the team developing therapies using various technologies such as gene therapy, anti-sense oligonucleotides, enzyme replacement therapy, small molecules among other treatment modalities.
Medical Degree (MD or MD/PhD).
5 + years of experience in pharmaceutical/biotechnology industry and academic clinical research experience.
Specialization in Genetics, Pediatrics, Neurology or Hematology preferred
Academic experience as a principal investigator a plus
Strong analytical thinking and the ability to assess scientific data and medical literature.
Excellent interpersonal skills, written and verbal communication skills.
Ability to write and review abstracts, scientific manuscripts and study reports strongly desired
Collaborative team work ethic.
The ability to explain difficult issues and work within a team structure to build consensus
A working knowledge of GCP
Sanofi US Services, 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.
The position is based in Cambridge, Massachusetts, USA.
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.
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