🧬 Job Title: Senior Clinical Research Director (I&I)
Locations: Bridgewater, New Jersey / Cambridge, Massachusetts, USA
Salary Range: USD 225,000 – 375,000 per year
Company: Sanofi
Therapeutic Area: Immunology & Inflammation (I&I)
Work Type: Onsite
🌍 About Sanofi
Sanofi is a global biopharmaceutical leader committed to chasing the miracles of science to improve lives. The company combines deep immunoscience, digital innovation, and AI-powered discovery to deliver transformative therapies in oncology, rare diseases, neurology, and vaccines.
🎯 Role Overview
The Senior Clinical Research Director (Sr. CRD) acts as the primary clinical lead for I&I programs.
This leadership position requires a strategic, organized, and collaborative professional who can balance clinical expertise, cross-functional coordination, and regulatory responsibilities.
The Sr. CRD drives clinical strategy, ensures operational excellence, and represents Sanofi’s I&I portfolio in internal and external forums — including interactions with global regulatory agencies.
⚙️ Key Responsibilities
1. Clinical Leadership
Serve as primary clinical lead across assigned I&I programs.
Mentor other Clinical Research Directors (CRDs) and Clinical Scientists.
Drive alignment across functions and therapeutic areas to ensure operational consistency (protocols, study documents, execution strategy).
Anticipate study-related challenges and coordinate proactive action plans.
2. Medical and Scientific Oversight
Provide medical expertise across all clinical studies and registries.
Lead and review clinical documentation: protocols, key results, study reports, and submissions.
Conduct medical review and validation of clinical data.
Oversee risk assessments, safety data review, and clinical feasibility evaluation.
3. Regulatory & Submission Support
Contribute to regulatory submission dossiers (FDA, EMA, PMDA, NMPA).
Lead the development of clinical sections of the CTD/BLA, briefing packages, and regulatory responses.
Participate as the medical spokesperson in meetings with global health authorities.
4. Strategic Contributions
Collaborate with internal stakeholders on Target Value Proposition (TVP), Target Product Profile (TPP), and market access strategies.
Provide clinical input into research direction and in-licensing evaluations.
Ensure that development strategies align with patient needs and emerging science.
5. Internal Governance & Cross-Functional Collaboration
Prepare and present materials for governance meetings.
Build consensus across Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Medical Affairs.
Share best practices and lessons learned across teams.
🧠 Key Qualifications
Education
Medical Doctor (MD) required — General Practitioner or Specialist.
Advanced scientific or clinical research background preferred.
Fluent in English (spoken and written).
Experience
Minimum 4+ years in the pharmaceutical industry or CRO.
Proven experience in clinical development, preferably within I&I or related therapeutic areas.
Strong understanding of regulatory submission requirements (FDA/EMA/ICH).
Prior leadership in multi-center, global clinical studies preferred.
💼 Core Skills
Strategic and analytical decision-making.
Excellent communication and scientific writing skills.
Emotional intelligence and motivational leadership.
Strong cross-functional collaboration and mentoring capability.
Experience in clinical data interpretation, risk management, and regulatory interactions.
🤝 Key Internal/External Collaborations
Internal:
Therapeutic Area Heads
Clinical Development, Operations, Regulatory Affairs, Pharmacovigilance
Medical Affairs, Market Access, and Research Strategy Teams
External:
Regulatory Agencies (FDA, EMA, PMDA, etc.)
Investigators, CROs, clinical vendors
Key Opinion Leaders (KOLs) and advisory boards
🌟 Why Work with Sanofi
Collaborate with world-class scientific and medical teams.
Opportunities for global mobility and leadership growth.
Comprehensive benefits, including:
Health and wellness programs
High-quality medical coverage
14 weeks of gender-neutral parental leave
Competitive pay aligned with experience and contribution.
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