medical affairs director ( clinical development).

We are seeking an experienced Director of Clinical Development to lead the formulation of global clinical development strategies, with a primary focus on ex-China regions (U.S. and Europe).

This role is central to designing and authoring the Clinical Development Plans (CDP) for their novel siRNA-based therapeutics, ensuring they are scientifically robust, aligned with regulatory expectations, and effectively support the progression of our pipeline toward global registration.

Clinical Strategy: Lead the development of comprehensive Global Clinical Development Plans (CDP) for assigned assets. This includes evaluating and selecting target indications, designing studies from First-in-Human (FIH) through pivotal trials, defining patient populations, and outlining a global registration pathway with a focus on the U.S. and European markets. The role is also responsible for formulating strategies for indication expansion.

about the manager/team
Individual contributor

skills and experience required

• A minimum of 8 years of direct experience in clinical development within the global biopharmaceutical industry.
• At least 3 years of proven experience in a role with primary responsibility for formulating clinical development strategy and authoring Clinical Development Plans (CDPs), specifically for programs targeting the U.S. and European markets.
• Hands-on experience with full-cycle clinical development (Phase I-III) for at least one asset.
• Experience contributing to major regulatory submissions (NDA/BLA/MAA) is a significant advantage.
• Demonstrated experience in evaluating and selecting target indications, and in planning for indication expansion, is highly preferred.

To apply online please use the 'apply' function, alternatively you may contact at .
(EA: 94C3609/ )