Job title: Senior Clinical Research Director
Main responsibilities:Clinical Development Strategy & Execution:
- 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 the 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 deep expertise in internal medicine, metabolic diseases, nephrology and rare disease biology.
- Integrate preclinical data, clinical pharmacology, and competitive intelligence to inform strategy.
- Champion innovative trial designs - adaptive, natural history, and real-world evidence - appropriate for rare disease contexts.
- Influence product value proposition through evidence-based input on unmet needs and development approaches.
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 all activities comply with FDA, EMA, CHMP, ICH guidance and Sanofi policies.
External Engagement & Dissemination:
- Drive timely publication of clinical data in peer-reviewed journals and at scientific congresses.
- Lead advisory board meetings and maintain strategic relationships with KOLs, patient advocacy organizations, and rare disease consortia.
Cross-Functional Collaboration:
- Align cross-functional stakeholders around a unified development vision; present CDPs to governance and senior leadership.
- Partner with Medical Affairs, Biostatistics, Translational Medicine, Regulatory, Market Access, and Commercial functions.
- Mentor Clinical Research Directors and Clinical Scientists and contribute to talent development within the Rare Disease TA.
About You- Education: MD or equivalent required
- Experience: 5+ years in drug development, or 5+ years pharmaceutical/biotech industry experience in clinical development.
- Rare Disease: Demonstrated experience with orphan drug frameworks and small patient population trial design.
- Technical Skills: Expertise in clinical pharmacology, biomarker strategy, benefit-risk assessment, and innovative trial designs.
- Leadership: Proven ability to lead cross-functional global teams without direct authority; strong negotiation and decision-making skills.
- Communication: Exceptional written and verbal English; ability to present to scientific, regulatory, executive, and patient audiences.
Preferred Qualifications:
- MD/PhD strongly preferred
- Board certification in metabolic medicine, medical genetics, nephrology, or cardiology.
- Direct experience with lysosomal storage disorders, enzyme replacement therapy, or gene therapy.
- Prior experience as medical spokesperson in FDA/EMA meetings.
- Familiarity with real-world evidence (RWE) in rare disease regulatory submissions.
- Peer-reviewed publication record in the relevant therapeutic area.
- Experience with business development and scientific due diligence.
The salary range for this position is:
$236,250.00 - $393,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
