Senior Vice President Clinical Development

HW3; United States; On-site; USD 350,000 - 600,000; Full time

Job summary

Hw3 Llc is seeking a Senior Vice President of Clinical Development with deep expertise in Immunology, Autoimmune diseases, and Rheumatology. The role oversees strategy and execution from early phases to pivotal trials and regulatory submissions.

The ideal candidate will have an MD and proven leadership of global Phase 3 programs, with extensive interactions with regulatory authorities and a hands-on biotech environment.

Qualifications

• MD required with extensive clinical development experience in biotech/pharma.
• Strong expertise in immunology, autoimmune diseases, and/or rheumatology.
• Proven experience leading early and late phase clinical development programs (Phase 1–3).
• Experience advancing programs from first in human studies through pivotal trials and registrations.
• Regulatory planning and interactions with authorities (FDA/EMA).

Responsibilities

• Provide strategic and medical leadership across clinical development programs.
• Oversee clinical strategy and execution from early phase through pivotal trials and regulatory submissions.
• Lead global Phase 3 trials and contribute to NDA/BLA/MAA submissions.
• Build and lead high-performing cross-functional clinical development teams.

Skills

MD

Clinical development leadership

Immunology

Autoimmune/Rheumatology

Global Phase 3 trials

Education

MD degree

Job description

Senior Vice President, Clinical Development | Immunology / Autoimmune / Rheumatology

We are hiring a Senior Vice President of Clinical Development on behalf of one of our biotech clients.

In this role, you will provide strategic and medical leadership across clinical development programs, overseeing clinical strategy and execution from early phase development through pivotal trials and regulatory submissions.

Key Experience & Qualifications:

• MD required, with extensive clinical development experience within biotech/pharma.
• Strong therapeutic expertise in immunology, autoimmune diseases, and/or rheumatology.
• Proven experience leading early and late phase clinical development programs (Phase 1–3).
• Experience advancing clinical programs from first in human studies through pivotal trials and registration.
• Strong expertise in clinical development strategy, trial design, protocol development, and regulatory planning.
• Experience leading global Phase 3 clinical trials and contributing to NDA/BLA/MAA submissions.
• Experience engaging with regulatory authorities, including the FDA and EMA.
• Strong scientific and medical leadership, including clinical data interpretation, benefit risk assessments, and development decision making.
• Demonstrated experience building and leading high performing, cross functional clinical development teams.
• Ability to provide strategic executive leadership while remaining hands on in a biotech environment.

Our team will review applications and reach out to candidates whose experience aligns with the role.