Job Title: Clinical Development Scientist, Neurology
Location: Cambridge, MA
About the Job
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?
The Clinical Research Director (CRD) is noted as the primary clinical expert for programs. The role requires a well-organized, strategic and operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.
Clinical Development Scientist
The main purpose of the CDS job role is to collaborate with the physicians, assisting GPH, Clinical lead and CRDs in activities around the compound, MA interactions, support in literature reviews, and follow some development activities as post-commitment studies.
The new recruiter will work with a team composed of clinical development experts, statisticians, clinical operations personnel, medical writers, safety experts, regulatory affairs, medical affairs and external key opinion leaders. He/She will develop some medical competencies in the disease and experimental therapy for which he/she is responsible.
Main Responsibilities:
Work with development physicians for the preparation of supportive documents for AdBoards and meetings with Regulatory Affairs
Literature review update related to external opportunities
Participates to the review of the list of countries for clinical studies and ensures alignment with Medical Affairs and Commercial teams on the business case for each country
Compiles regulatory, launch and reimbursement status in collaboration with regulatory, commercial and market access teams.
Collaboration and interaction with the Project Team members and the Project Leader and with the other departments of the Neurology TA (clinical pharmacology, Global Safety Officer, biostatistics, regulatory, Medical affairs and commercial teams) to facilitate the preparation of deliverables that need various contribution.
Contribute to the preparation of clinical sections of protocols, key result memo, clinical study reports, regulatory agency update reports, and other clinical and regulatory documents with focus on more routine/standard document elements describing all clinical procedures/ or studies to be included in this respective documents.
Participates to the review of scientific publications and communications to ensure data accuracy with source documentation such as CSR.
Provides support for the preparation of presentations used for different committees (BRAC, TARC, , , GPTM, STF, DWG...)
Participate at Global program level meetings, such as, , GPTM, , STF Requested Profile
Educational background : Scientific medical degree (PhD) with strong experience (>10 years) in Pharma business across different entities (R&D and Medical Affairs)
Experience in KOL interactions, in data review and interpretation, in manuscripts and abstracts preparation
Knowledge of Pharmacovigilance and CMC landscape, of project planning tools
Understanding of clinical research process from program planning to regulatory submission
About You:
Professional and behavioral competencies
Ability to drive and coordinate activities including prioritizing capacity, issue identification and resolution
Ability to motivate the team towards advancing the project according to milestones and delivering good quality data
Ability to work, network and communicate with a global product team, in an international matrix organization and across companies in co- development projects
Ability to interact productively with external investigators
Strategic thinking, analytic and synthetic capacity
Team spirit and teamwork ability
Must have good communication (oral and written) skills Language skills
Fluent in English
French or a third language might be advantageous
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.
