Senior Clinical Research Director
Job Title
Location
About the Job
About Sanofi
Main Responsibilities
Leadership & Mentorship
- Act as a mentor for other CRDs and Clinical Scientists within the same project or therapeutic area
- Provide leadership, build consensus, and coordinate action plans with other CRDs and stakeholders to resolve project-related study issues
- Anticipate potential issues by sharing lessons learned across project and study teams
- Raise study or project-level issues to TA Heads as relevant, and share pertinent information within and beyond project teams
Cross-Functional Collaboration
- Collaborate with functions to ensure a uniform, aligned operational approach (e.g., harmonizing study documents, endpoints, protocols)
- Interact with other CRDs in the project, Global Project Head, PV Representatives, Regulatory, and other key functional representatives
Clinical Research & Development (CRD Role)
- Provide medical expertise to clinical studies (except select Exploratory Pharmacology studies) and/or registries, including protocol development, Key Results, and Clinical Study Reports
- Support other clinical development activities such as pressure testing and cluster feasibility, medical review and validation of clinical data, and study risk assessment
- Contribute to the clinical part of submission dossiers, including Common Technical Documents for FDA & EMA submissions, filings in Japan and China, and responses to health authority questions
- Provide appropriate medical input and support for all activities related to clinical studies, including medical training, feasibility assessments, medical review of data, and medical information for study teams, medical advisors, Clinical Project Leaders from Clinical Study Units, and investigators
- Serve as the medical reference within the Clinical Study team, ensuring the medical relevance and integrity of clinical data
Experience & Competencies
- Understanding of pharmaceutical product development and life cycle management gained through approximately 4 years of clinical development and medical experience
- Excellent scientific and medical/clinical expertise
- Excellent expertise in clinical development methodology and design of clinical studies
- Excellent communication skills (verbal and written) for interactions across functional areas and with key regulatory agencies
- Demonstrated capability to challenge decisions and the 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
- Excellent teaching skills with a demonstrated ability to assist and train others
- Ability to work effectively within a matrix model
- Strong international/intercultural working skills
- Open-minded and adaptable to new digital solutions
Qualifications
- MD or equivalent medical degree is required (DO, MBBS)
- Medical training or clinical development experience in rheumatology, hematology, transplant, or immunology
- At least 4 years in the pharmaceutical industry (experience in late-stage clinical development preferred)
- English fluency (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 it’s 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 #LI-SA #LI-Hybrid #vhd
Pursue progress , discover extraordinary
Not included in the source posting: benefits.
Skills
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