Senior Clinical Research Director, Rare Disease

Sanofi

Senior Clinical Research Director leading clinical development strategy and execution for rare disease programs. Collaborating across teams to drive programs from development to registration with patient-centric focus.

Posted 5/20/2026full-timeCambridge • Massachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $236,250 - $393,750 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

shape and execute clinical development strategy for assigned rare disease programs
drive programs from early development through registration with a patient-centric focus
serve as a recognized scientific authority within the Rare Disease TA
lead design and authorship of study synopses, CDPs, and clinical sections of IDPs
oversee end-to-end trial execution through cross-functional units, ensuring GCP and regulatory compliance
define and manage timelines, budgets, and risk mitigation strategies
serve as strategic clinical lead and medical spokesperson within the Global Project Team, Protocol Review Committee and Executive Leadership
contribute to biomarker identification and provide due diligence support for business development opportunities
drive timely publication of clinical data in peer-reviewed journals and at scientific congresses
align cross-functional stakeholders around a unified development vision; present CDPs to governance and senior leadership
mentor Clinical Research Directors and Clinical Scientists and contribute to talent development within the Rare Disease TA

Requirements

What you’ll need

MD required; MD/PhD strongly preferred; medical degree from LCME-accredited or equivalent institution
10+ years in drug development, or 10+ years pharmaceutical/biotech industry experience in clinical development
Demonstrated experience with orphan drug frameworks and small patient population trial design
Expertise in clinical pharmacology, biomarker strategy, benefit-risk assessment, and innovative trial designs
Proven ability to lead cross-functional global teams without direct authority; strong negotiation and decision-making skills
Exceptional written and verbal English; ability to present to scientific, regulatory, executive, and patient audiences.

Benefits

Comp & perks

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical development strategystudy synopses designclinical development plans (CDPs)clinical trial executionbiomarker identificationbenefit-risk assessmentorphan drug frameworksinnovative trial designsregulatory complianceGCP (Good Clinical Practice)

Soft Skills

leadershipnegotiationdecision-makingmentoringcommunicationpresentation skillsstakeholder alignmentstrategic thinkingcross-functional collaborationtalent development

Certifications

MDMD/PhD