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About the Company
Our client is a clinical-stage biotechnology company advancing a next-generation RNA interference (RNAi) platform to deliver transformative therapies. Their pipeline is focused on addressing significant unmet needs across metabolic, cardiovascular, and select complementary therapeutic areas, with multiple siRNA programs progressing through clinical development.
About the Role
We are partnering with a growing biotech to appoint a Director of Clinical Development to drive global clinical development strategy, with a strong emphasis on ex-China programs, particularly across the U.S. and Europe.
This role will play a pivotal role in shaping the clinical roadmap for novel siRNA-based therapeutics, leading the design and authorship of Clinical Development Plans (CDPs) that are scientifically rigorous, regulatory-aligned, and positioned to support global registration.
Key Responsibilities
Clinical Development Strategy
Lead the development of end-to-end Global Clinical Development Plans (CDPs) for assigned assets.
Define and evaluate target indications, including strategies for indication expansion.
Design clinical programs spanning First-in-Human through pivotal Phase III studies.
Identify optimal patient populations, endpoints, and study designs aligned with regulatory expectations.
Develop a clear global registration strategy, with primary focus on the U.S. FDA and EMA pathways.
Collaborate cross-functionally to ensure clinical strategy supports overall pipeline and corporate objectives.
This is a high-impact individual contributor role with significant strategic ownership.
Skills & Experience
8+ years of experience in clinical development within the global biopharmaceutical industry.
3+ years in a role with primary accountability for clinical development strategy and CDP authorship, specifically for U.S. and European programs.
Direct, hands-on experience across Phase IIII clinical development for at least one asset.
Experience supporting major regulatory submissions (NDA, BLA, and/or MAA) is highly advantageous.
Strong track record in indication selection and expansion planning.
Background or exposure to Hematology and/or Renal disease areas is preferred.
Qualifications & Education
Medical Doctor (MD) required
PhD in a relevant scientific discipline (e.g. Clinical Pharmacology, Biomedical Sciences)
Doctorate-level education is essential
Please reach out to Kay Dhupar at [Confidential Information] for a confidential discussion.
Job ID: 143382593