SVP, Head of Clinical Development

Kaye/Bassman International; United States; On-site; USD 350,000 - 650,000; Full time

Job summary

Kaye/Bassman International, partnering with a well-funded clinical-stage biopharmaceutical company, seeks its first U.S.-based Head of Clinical Development to lead global clinical strategy from the ground up with direct exposure to the Board and senior leadership.

The role defines the U.S. development plan across immunology and related areas, guides trial design, and oversees regulatory affairs, data management, and medical writing. Travel to the U.S. and China will be required.

Qualifications

• MD required; specialization in nephrology or 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.

Responsibilities

• 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.

Skills

Clinical trial design

Regulatory affairs

Biomarker strategy

Translational research

Leadership

Investor/KOL communication

Education

MD

Job description

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