Vice President Clinical Development – United States Commercial-Stage Biotechnology Company

Vice President Clinical Development – USA

Location – United States

About The Role

Our client is a commercial-stage biotechnology company focused on the discovery, development, manufacturing, and commercialisation of innovative therapies for patients with serious diseases and high unmet medical needs. Headquartered in PA, the company has built an integrated platform spanning research, clinical development, manufacturing, and commercial operations.

With an approved therapy already on the market and a growing pipeline of investigational programmes, the organisation is advancing multiple assets across dermatology, ophthalmology, and pulmonology. The company maintains operations across North America, Europe, and Asia and is continuing to expand its global development footprint.

The Opportunity

This is an opportunity to join a rapidly growing biotech at a pivotal stage of expansion. As VP of Clinical Development, you will provide strategic and medical leadership across programmes from clinical development through registration and post-marketing activities.

You will work closely with cross-functional internal teams, regulatory agencies, investigators, academic collaborators, and patient advocacy organisations to advance therapies intended to address significant unmet medical needs.

What You’ll Do

• Lead clinical development programmes across multiple therapeutic areas from early clinical stages through registration and lifecycle management.
• Author and review clinical development plans, protocols, investigator brochures, study reports, and regulatory documentation.
• Provide medical monitoring and safety oversight, including review of eligibility, adverse events, and safety reporting activities.
• Represent the company in interactions with FDA, EMA, and other regulatory authorities.
• Collaborate with Clinical Operations and external partners on trial execution and study oversight.
• Engage with investigators, thought leaders, and advocacy groups to support study design and interpretation of results.
• Support patient recruitment and engagement strategies in collaboration with study sites.
• Contribute to publications, scientific presentations, and medical affairs activities.

What We’re Looking For

Required

• MD degree or equivalent.
• Minimum 10 years of clinical development experience within the biopharmaceutical industry.
• Demonstrated experience supporting successful regulatory submissions and approvals.
• Strong knowledge of FDA and EMA regulations, GCP, and ICH guidelines.
• Experience leading interactions with regulatory agencies.
• Strong medical monitoring and clinical safety oversight experience.
• Excellent written and verbal communication skills.
• Proven ability to work effectively within cross-functional environments.

Preferred

• Background in dermatology, ophthalmology, pulmonology, or rare disease.
• Experience with advanced therapeutics, biologics, or innovative treatment modalities.
• Existing relationships with investigators, advocacy organisations, or academic centres.
• Experience within a commercial-stage or high-growth biotech environment.