Vice President, Clinical Development

Fairway Consulting Group; United States; On-site; USD 260,000 - 380,000; Full time

Benefits offered by this job

Health insurance

Bonus potential

Job summary

Fairway Consulting Group client seeks a Vice President, Clinical Development to lead immunology-focused strategy, trial design, and regulatory interactions. The role directs early-phase programs, mentors teams, and partners with cross-functional leaders across global development efforts.

The candidate will drive IND/CTA engagements, data interpretation, and external collaborations while ensuring scientific rigor and clinical relevance across a growing portfolio.

Qualifications

• MD or MD/PhD with immunology or immune-mediated disease focus.
• Experience leading early-stage clinical programs.
• Phase 1/2 trial design and execution experience.
• Track record with INDs/CTAs and regulatory interactions.
• Global cross-functional leadership across US/Europe.

Responsibilities

• Serve as internal clinical expert in immunology to guide strategy and development opportunities.
• Develop integrated clinical development plans for immune-mediated diseases.
• Lead protocol development, medical monitoring, data review and safety oversight.
• Collaborate with Regulatory Affairs, Biometrics, and Operations to drive execution.
• Represent the company in external collaborations and regulatory discussions.
• Interface with FDA/EMA and advise on development and registrational strategies.
• Engage investigators and key opinion leaders to inform strategy and enrollment.
• Mentor teams as pipeline expands and transition programs to later stages.
• Present data and strategic recommendations to leadership and governance bodies.

Skills

Immunology expertise

Clinical leadership

Regulatory interactions

Cross-functional collaboration

Strategic thinking

Leadership presence

Education

MD or MD/PhD

Rheumatology/Immunology training

Job description

Our client is a clinical-stage biotechnology company focused on developing innovative therapies for immunological and immune-mediated diseases. They have asked us to assist them in their search for a Vice President, Clinical Development.

Responsibilities:

• Serve as a key internal clinical expert in immunology and immune-mediated diseases, advising senior leadership and cross-functional teams on disease biology, emerging science, indication strategy, and clinical development opportunities.
• Develop and lead integrated clinical development plans for programs targeting immune-mediated and autoimmune diseases.
• Apply immunology and clinical development expertise to indication selection, target product profiles, patient segmentation, biomarker strategy, trial design, and interpretation of clinical and translational data.
• Design and oversee Phase 1 and Phase 2 clinical trials and pre‑registrational studies, ensuring scientific rigor, regulatory alignment, operational feasibility, and commercial relevance.
• Provide clinical leadership across a growing pipeline of clinical and preclinical development programs.
• Lead protocol development, medical monitoring, data review, interpretation, and clinical decision‑making to protect patient safety and ensure data quality.
• Partner closely with Clinical Operations, Regulatory Affairs, Biometrics, Translational Medicine, Research, and program leadership to drive timely and disciplined execution.
• Serve as a key clinical representative in external collaborations and strategic partnerships, contributing to development strategy, governance, and program execution.
• Lead clinical interactions with the FDA, EMA, and other health authorities, including IND and CTA submissions, scientific advice meetings, and discussions supporting development and registrational strategies.
• Engage investigators, key opinion leaders, patient communities, and advisory boards to inform indication strategy, trial design, enrollment, and broader development plans.
• Collaborate with senior leadership and cross‑functional teams to establish priorities, resolve issues, and maintain accountability across the portfolio.
• Support the transition of programs into later‑stage development. Direct Phase 3 leadership experience is valued but not required.
• Build and mentor clinical development capabilities as the organization and pipeline expand, fostering a culture of collaboration, urgency, accountability, and scientific excellence.
• Present clinical data, scientific insights, and development recommendations to senior leadership, the Board of Directors, external partners, and other stakeholders.
• Contribute to abstracts, publications, and scientific presentations communicating clinical and scientific findings to the broader medical and scientific communities.

We seek candidates with the following qualifications:

• MD or MD/PhD required, along with relevant specialty training and meaningful experience in immunology or immune‑mediated diseases.
• Training as a rheumatologist, allergist/immunologist, or internist with significant immunology experience is strongly preferred.
• Scientific and clinical credibility to serve as an internal resource on immune‑mediated diseases, immunology, and the clinical application of emerging science.
• Significant clinical development experience within the biotechnology or pharmaceutical industry, including direct leadership of early‑stage clinical programs.
• Demonstrated experience designing and executing Phase 1 and Phase 2 trials. Phase 3 or registrational experience is beneficial but not required.
• Strong knowledge of autoimmune or immune‑mediated disease, inflammation, and immune‑system modulation.
• Experience with immune‑modulating biologics or other novel therapeutic modalities is a plus.
• A track record of productive regulatory interactions and experience supporting INDs, CTAs, or related clinical submissions.
• Experience working across global and highly distributed teams. Exposure to both U.S. and European development environments is preferred.
• Strong collaboration and partnership‑management skills, with the ability to operate effectively across multiple organizations, functions, and geographies.
• Clinical judgment and intellectual agility to work across multiple indications and an expanding development pipeline.
• A self‑directed, hands‑on leadership style, with the ability to move comfortably between high‑level strategy and detailed execution.
• Strong cross‑functional collaboration skills and the ability to establish effective working relationships with Clinical Operations, Regulatory Affairs, Research, program management, and external partners.
• Clear and credible communication skills, with the ability to engage regulators, investigators, executives, board members, and employees.