Clinical Research Director
Location: Morristown, NJ & Cambridge, MA
Employment: Permanent
Salary Range: USD 201,000 - 335,000
Posted on: Apr. 04, 2025
Closing on: Aug. 01, 2025
Company: Sanofi
Job Summary:
The Clinical Research Director (CRD) for Immunology & Inflammation (I&I) Therapeutic Area at Sanofi will lead the clinical development strategy for assets in Dermatology. The CRD will work closely with cross-functional teams to execute clinical trials, design clinical study protocols, and provide scientific and clinical leadership to advance immunology treatments. This role requires extensive expertise in dermatology and clinical research, as well as leadership capabilities to engage with stakeholders and drive clinical development forward.
Main Responsibilities:
Clinical Development Strategy:
Create and document the clinical development plan (CDP) in alignment with project strategy, working with global project teams and internal partners (clinical operations, translational medicine, regulatory affairs, etc.).
Lead a clinical subteam to design clinical studies and create clinical study protocols.
Study Execution and Compliance:
Oversee execution of clinical studies in compliance with SOPs, GCP, ICH guidelines, and regulatory requirements.
Review key documents, including Investigator's brochures, regulatory documents, and clinical sections of development plans.
Regulatory Support:
Support drug registration processes, contribute to submission dossiers, and prepare for advisory committees.
Represent Clinical Development in Health Authority meetings and incorporate feedback into strategy.
Data Review and Interpretation:
Contribute to data review, interpretation, and publication of clinical study results.
External Scientific Collaboration:
Build and maintain relationships with external scientific communities, integrating relevant insights into the program.
Align clinical strategy with partners in alliance projects and evaluate business development opportunities.
Leadership and Ethical Standards:
Lead with integrity and apply high ethical standards in clinical research.
Contribute to the scientific and technical expertise in dermatology and translational medicine.
Scientific and Technical Expertise:
Requirements:
Medical Doctor, board-certified or equivalent in dermatology or allergy/immunology.
Over 5 years of clinical/scientific experience, or >10 years of industry experience in dermatology.
Strong background in clinical research, drug development, and translational medicine in the dermatology therapeutic area.
Excellent problem-solving, conflict-resolution, and decision-making skills.
Knowledge of clinical pharmacology, biomarkers, clinical trial designs, and statistical methods.
About You:
Qualifications:
Medical degree (MD), board certification or equivalent in dermatology or allergy/immunology.
More than 5 years of clinical or scientific and/or >10 years of industry experience within dermatology.
Strong scientific and academic background within clinical research, pharmaceutical or experimental medicine.
Exceptional interpersonal, communication, and leadership skills.
Why Choose Us?
Growth Opportunities:
Endless opportunities to grow your talent and drive your career, both domestically and internationally.
Rewards and Benefits:
Thoughtful rewards package that recognizes your contribution, with excellent healthcare and wellness benefits, including gender-neutral parental leave.
Commitment to Diversity:
Sanofi is an Equal Opportunity employer, fostering a diverse and inclusive workplace.
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