VP Therapeutic Strategy - Immunology Autoimmune

Warman O’Brien is delighted to partner on the appointment of a VP, Therapeutic Strategy – Immunology & Autoimmune.

This is a senior strategic role with a global leader in clinical development, offering the opportunity to shape early clinical and regulatory strategies for sponsors developing treatments in immunology and autoimmune indications. Ideal if you're looking to remain at the forefront of regulatory science without the burden of operational delivery.

Key Responsibilities

• Lead early clinical trial strategy, including endpoint selection, protocol direction, and regulatory positioning.
• Advise biotech and pharma sponsors on integrated development plans, ensuring alignment with FDA expectations.
• Partner closely with internal teams and external clients to drive smart, streamlined trial designs for rare and paediatric diseases.
• Provide therapeutic and regulatory guidance from preclinical through to market planning stages.
• Contribute to business development and bid strategy by representing the scientific and regulatory point of view.
• Attend key global scientific meetings to remain current on regulatory trends and development methodologies.

Required Skills & Experience

• M.D. with board certification
• Must be up to date with current FDA guidelines and expectations, prior experience within the FDA strongly preferred
• Strong understanding of global drug development with deep expertise in regulatory expectations, particularly within immunology and/or autoimmune
• Experience advising sponsors either within a consultancy, small biotech, or CRO
• Excellent communication and stakeholder engagement skills; fluent in English

This is a front-end, strategic role perfect for those who love thinking, guiding, and shaping early clinical plans, not managing execution.

Please get in touch if you’d like to learn more or recommend someone in your network.