SVP, Head of Clinical Development

About the role
Kaye/Bassman is partnering with a well-funded, clinical-stage biopharmaceutical company on a search for its first U.S.-based Head of Clinical Development. The company has built a large internally derived pipeline in immunology and inflammation, with multiple programs in the clinic and a first commercial launch expected soon in its home market. It is now expanding into the United States and preparing for a public listing.
This is a rare chance to build and lead the company’s U.S. clinical strategy from the ground up, with global responsibility and direct exposure to the Board and senior leadership.
What you will do
Define and own the company’s global clinical strategy and U.S. development plan, from preclinical research through registrational studies
Assess U.S. market opportunities and build a durable strategy for bringing programs into the U.S.
Guide the design of full-cycle clinical trials and development plans across immunology, nephrology, and related areas
Direct clinical development, regulatory affairs, data management, drug safety, and medical writing, in a hands-on role
Lead FDA and other health authority interactions and review the medical content of regulatory dossiers
Serve on the scientific committee advising on trials in China, working with the leader of China development
Represent the company to KOLs, regulators, strategic partners, and investors, including financing and IPO roadshow presentations
Support business development, partnering, and due diligence
Build the U.S. clinical team and mentor leaders across the organization
What you bring
MD required; specialization in nephrology or an autoimmune-related field strongly preferred
10+ years in senior clinical leadership roles in biotech or pharma, with a focus on autoimmune and chronic inflammatory disease
Proven record in clinical trial design, protocol writing, biomarker strategy, and translational research
Phase 1 through Phase 3 experience, plus experience leading FDA and global health authority interactions
Small molecule experience highly desirable
Experience leading an organization through growth and change
Prior exposure to the Chinese biotech or pharma industry preferred; Mandarin is a plus
Strong communication skills and credibility with investors, KOLs, and global partners
Willingness to travel within the U.S. and to China as needed