Senior Clinical Research Director, I&I

About The Job

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.

Main Responsibilities

• Act as a mentor for other CRDs and Clinical Scientists on a same project/TACollaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc).
• As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipate potential issues (sharing lessons learned) across the project or study teams.
• Raise study or project-level issues to TA Heads, as relevant and share relevant information within and beyond Project teams.
• Take on as necessary the CRD role:
• Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)
• Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
• Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
• Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps

Experience About You

• Understanding of pharmaceutical product development and life cycle management gained through ~4 years of clinical development and medical experience
• Excellent Scientific and medical / clinical expertise
• Excellent expertise in clinical development and methodology of clinical studies
• Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
• Demonstrated capability to challenge decision and status quo with a risk-management approach
• Ability to negotiate to ensure operational resources are available for continued clinical conduct
• Fluency in written and spoken English
• Demonstrated ability to assist and train others
• Ability to work within a matrix model
• International/ intercultural working skills
• Open-minded to apply new digital solutions

Minimum Level Of Any Required Qualifications

• MD or eqivalent (DO, MBBS)
• Specialization and training as a Rheumotologist
• At least 4 years in pharmaceutical industry or CRO, previous experience in late stage clinical development
• English fluent (spoken and written)

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 its through a promotion or a 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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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 #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.