Senior Clinical Research Director, Rare Disease
Sanofi
11 hours ago
Remote friendly (Morristown, NJ)
United States
$236,250 - $393,750 USD yearly
Clinical Research and Development
Position Overview:
Senior Clinical Research Director (sCRD), Rare Disease is responsible for shaping and executing clinical development strategy for assigned rare disease programs, driving studies from early development through registration with a patient-centric focus.
Key Responsibilities:
- 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 with Clinical Operations, Project Management, and Procurement.
- Serve as strategic clinical lead and medical spokesperson within Global Project Team, Protocol Review Committee, and Executive Leadership.
- Contribute to biomarker identification and provide due diligence support for business development opportunities.
Scientific Leadership:
- Maintain expertise in internal medicine, metabolic diseases, nephrology and rare disease biology.
- Integrate preclinical data, clinical pharmacology, and competitive intelligence.
- Champion adaptive, natural history, and real-world evidence trial designs for rare disease contexts.
Regulatory Strategy:
- Lead programs at key regulatory interactions (FDA, EMA, PMDA) as primary medical spokesperson.
- Develop engagement strategies for pre-IND, End-of-Phase meetings, and Advisory Committee preparations.
- Support label development, registration submissions, and post-approval modifications; ensure compliance with FDA/EMA/CHMP/ICH guidance and company policies.
Required Qualifications:
- MD required; MD/PhD strongly preferred; medical degree from LCME-accredited or equivalent.
- 10+ years drug development or 10+ years pharmaceutical/biotech clinical development.
- Demonstrated orphan drug frameworks and small patient population trial design.
- Expertise in clinical pharmacology, biomarker strategy, benefit-risk assessment, and innovative trial designs.
- Ability to lead global cross-functional teams without direct authority; strong negotiation/decision-making.
- Exceptional written/verbal English; ability to present to scientific, regulatory, executive, and patient audiences.
Preferred Qualifications:
- Board certification in metabolic medicine, medical genetics, nephrology, or cardiology.
- Experience with lysosomal storage disorders, enzyme replacement therapy, or gene therapy.
- Medical spokesperson experience (FDA/EMA); familiarity with RWE in rare disease regulatory submissions.
- Peer-reviewed publications; business development and scientific due diligence experience.
Benefits (explicitly stated):
- At least 14 weeks’ gender-neutral parental leave.
Location:
Cambridge, MA / Morristown, NJ
Senior Clinical Research Director (sCRD), Rare Disease is responsible for shaping and executing clinical development strategy for assigned rare disease programs, driving studies from early development through registration with a patient-centric focus.
Key Responsibilities:
- 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 with Clinical Operations, Project Management, and Procurement.
- Serve as strategic clinical lead and medical spokesperson within Global Project Team, Protocol Review Committee, and Executive Leadership.
- Contribute to biomarker identification and provide due diligence support for business development opportunities.
Scientific Leadership:
- Maintain expertise in internal medicine, metabolic diseases, nephrology and rare disease biology.
- Integrate preclinical data, clinical pharmacology, and competitive intelligence.
- Champion adaptive, natural history, and real-world evidence trial designs for rare disease contexts.
Regulatory Strategy:
- Lead programs at key regulatory interactions (FDA, EMA, PMDA) as primary medical spokesperson.
- Develop engagement strategies for pre-IND, End-of-Phase meetings, and Advisory Committee preparations.
- Support label development, registration submissions, and post-approval modifications; ensure compliance with FDA/EMA/CHMP/ICH guidance and company policies.
Required Qualifications:
- MD required; MD/PhD strongly preferred; medical degree from LCME-accredited or equivalent.
- 10+ years drug development or 10+ years pharmaceutical/biotech clinical development.
- Demonstrated orphan drug frameworks and small patient population trial design.
- Expertise in clinical pharmacology, biomarker strategy, benefit-risk assessment, and innovative trial designs.
- Ability to lead global cross-functional teams without direct authority; strong negotiation/decision-making.
- Exceptional written/verbal English; ability to present to scientific, regulatory, executive, and patient audiences.
Preferred Qualifications:
- Board certification in metabolic medicine, medical genetics, nephrology, or cardiology.
- Experience with lysosomal storage disorders, enzyme replacement therapy, or gene therapy.
- Medical spokesperson experience (FDA/EMA); familiarity with RWE in rare disease regulatory submissions.
- Peer-reviewed publications; business development and scientific due diligence experience.
Benefits (explicitly stated):
- At least 14 weeks’ gender-neutral parental leave.
Location:
Cambridge, MA / Morristown, NJ