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Clinical Research Director, I And I, Pulmonology

0-2 years
$201,000.00 - $335,000.00
10 Sept. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Clinical Research Director, Immunology & Inflammation (I&I), Pulmonology

Location:

  • Cambridge, MA

  • Morristown, NJ

Salary Range:

USD 201,000 – 335,000


About the Job

Sanofi is accelerating drug discovery and development to improve patient lives. The Clinical Research Director (CRD), I&I Therapeutic Area, will lead clinical development strategy and execution, focusing on immunology with a specialization in Pulmonology. This role requires advancing scientific and clinical knowledge, incorporating novel methodologies, and driving study execution in alignment with corporate strategy.


Main Responsibilities

  • Clinical Development Strategy

    • Create and maintain the Clinical Development Plan (CDP) for assigned assets.

    • Collaborate with cross-functional global project teams (clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing).

    • Advance CDP through governance and internal review.

  • Clinical Study Leadership

    • Lead a clinical subteam to design studies and draft clinical study protocols.

    • Oversee clinical study execution ensuring compliance with SOPs, ICH/GCP, and regulatory standards.

    • Review essential study documents (Investigator’s Brochure, IND/CTA submissions, clinical sections of development plans, and regulatory dossiers).

  • Regulatory & Submission Support

    • Support global drug registrations (label drafts, responses to regulatory queries, advisory committee preparations).

    • Represent Clinical Development at Health Authorities and incorporate feedback into development strategy.

  • Scientific Contribution

    • Contribute to clinical data review, interpretation, and publication.

    • Maintain external engagement with scientific and clinical communities to integrate best practices and novel approaches.


Scientific & Technical Expertise Required

  • Strong foundation in internal medicine (Pulmonology expertise preferred).

  • Experience advancing assets from discovery to clinical development.

  • Knowledge in translational medicine, novel biomarkers, precision medicine, innovative trial designs, and statistical methods.

  • Ability to translate disease pathogenesis into measurable outcomes and clinical trial endpoints.

  • Deep scientific, technical, and clinical knowledge in immune-driven diseases and clinical immunology.

  • Problem-solving mindset and ability to stay updated on preclinical, pharmacology, and clinical data.


Basic Qualifications

  • Medical Degree (MD) – Board certification or equivalent in Internal Medicine/Clinical Immunology; Pulmonology is a plus.

  • Education from an LCME-accredited or equivalent medical school.

  • Relevant clinical, scientific, and/or industry experience in immune-driven diseases (Pulmonology preferred).

  • Strong academic and research background in clinical research, pharma, or experimental medicine.

  • Knowledge of drug development processes.

  • Strong interpersonal, communication, presentation, negotiation, and networking skills.

  • Ability to work within timelines in a global, cross-cultural environment.


Why Choose Us?

  • Shape the future of medicine and bring science to life.

  • Career growth through promotions, lateral moves, and international opportunities.

  • Comprehensive rewards package recognizing contribution and amplifying impact.

  • Health and wellbeing benefits including:

    • High-quality healthcare

    • Prevention & wellness programs

    • At least 14 weeks of gender-neutral parental leave


Diversity & Inclusion

Sanofi is an Equal Opportunity and Affirmative Action Employer. We value diversity, equity, and inclusion, ensuring equal consideration for all applicants regardless of race, gender, identity, orientation, age, disability, or veteran status.