Clinical Lead, I&I

3+ years

USD 225,000.00 - 375,000.00

Cambridge Massachusetts

10 April 22, 2025

Job Description

Job Type: Full Time Education: MD/DO 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

Clinical Lead, I&I
Location: Cambridge, MA or Morristown, NJ
Employment: Permanent
Salary Range: USD 225,000 - 375,000
Posted on: Apr. 03, 2025
Closing on: Jul. 28, 2025
Company: Sanofi

Job Summary:
The Clinical Lead, I&I will be responsible for leading the clinical development strategies for autoimmunity programs within immunology and inflammation (I&I) indications. This role requires a strategic, experienced, and resourceful individual capable of overseeing clinical activities, guiding a team of Clinical Research Directors, and supporting regulatory filings.

Main Responsibilities:

Clinical Development & Leadership:
- Lead clinical development plans for autoimmunity programs in I&I indications and coordinate clinical activities across indications and therapeutic areas.
- Lead a team of Clinical Research Directors (CRDs) and Clinical Scientists, overseeing study activities such as protocol development, medical review of clinical data, and risk assessments.
Regulatory & Clinical Documentation:
- Contribute to regulatory submissions and responses to health authorities.
- Oversee clinical input for key regulatory documents, including Investigator Brochures, CTAs, INDs, DSURs, and Risk Management Plans.
- Provide medical input for internal governance milestones and contribute to clinical documentation for FDA, EMA, and global regulatory filings.
Study Management & Execution:
- Oversee the preparation, review, and validation of clinical protocols, amendments, and supporting documents.
- Ensure timely and compliant execution of clinical trials in line with GCP, SOPs, timelines, and budgets.
- Provide continuous medical review of aggregated clinical data and guide the study team on feasibility, safety, and statistical outputs.
Collaboration & Stakeholder Management:
- Engage with internal and external stakeholders, including health authorities, to ensure alignment on clinical development strategies.
- Lead clinical discussions at advisory boards and conferences, participating in the development of manuscripts and abstracts.
Strategic & Operational Leadership:
- Collaborate with cross-functional teams to harmonize study documents and resolve study-related issues.
- Contribute to the development of market access strategies and the clinical value proposition for products.

Experience & Qualifications:

Medical Education:
- Medical Doctor (MD) with experience in internal medicine and immune-driven diseases.
Professional Experience:
- 5-10 years of clinical development experience in autoimmune diseases.
- Strong understanding of pharmaceutical product development and life cycle management.
- Proven ability to work within a matrix model, influence stakeholders, and ensure resource availability.
Skills & Abilities:
- Excellent verbal and written communication skills.
- Ability to lead strategic initiatives, influence decisions, and manage complex clinical projects.
- Open-minded and comfortable applying new digital solutions to enhance clinical practices.

Why Choose Us?

Growth Opportunities:
- A supportive and dynamic team offering ample career advancement and development opportunities globally.
Comprehensive Benefits:
- High-quality healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.
Commitment to Diversity:
- Sanofi is an Equal Opportunity and Affirmative Action employer, promoting a culturally diverse workforce.

Slug:

Main Responsibilities:

Clinical Development & Leadership:
- Lead clinical development plans for autoimmunity programs in I&I indications and coordinate clinical activities across indications and therapeutic areas.
- Lead a team of Clinical Research Directors (CRDs) and Clinical Scientists, overseeing study activities such as protocol development, medical review of clinical data, and risk assessments.
Regulatory & Clinical Documentation:
- Contribute to regulatory submissions and responses to health authorities.
- Oversee clinical input for key regulatory documents, including Investigator Brochures, CTAs, INDs, DSURs, and Risk Management Plans.
- Provide medical input for internal governance milestones and contribute to clinical documentation for FDA, EMA, and global regulatory filings.
Study Management & Execution:
- Oversee the preparation, review, and validation of clinical protocols, amendments, and supporting documents.
- Ensure timely and compliant execution of clinical trials in line with GCP, SOPs, timelines, and budgets.
- Provide continuous medical review of aggregated clinical data and guide the study team on feasibility, safety, and statistical outputs.
Collaboration & Stakeholder Management:
- Engage with internal and external stakeholders, including health authorities, to ensure alignment on clinical development strategies.
- Lead clinical discussions at advisory boards and conferences, participating in the development of manuscripts and abstracts.
Strategic & Operational Leadership:
- Collaborate with cross-functional teams to harmonize study documents and resolve study-related issues.
- Contribute to the development of market access strategies and the clinical value proposition for products.

Experience & Qualifications:

Medical Education:
- Medical Doctor (MD) with experience in internal medicine and immune-driven diseases.
Professional Experience:
- 5-10 years of clinical development experience in autoimmune diseases.
- Strong understanding of pharmaceutical product development and life cycle management.
- Proven ability to work within a matrix model, influence stakeholders, and ensure resource availability.
Skills & Abilities:
- Excellent verbal and written communication skills.
- Ability to lead strategic initiatives, influence decisions, and manage complex clinical projects.
- Open-minded and comfortable applying new digital solutions to enhance clinical practices.

Why Choose Us?

Growth Opportunities:
- A supportive and dynamic team offering ample career advancement and development opportunities globally.
Comprehensive Benefits:
- High-quality healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.
Commitment to Diversity:
- Sanofi is an Equal Opportunity and Affirmative Action employer, promoting a culturally diverse workforce.

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Clinical Lead, I&I

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