About the Company

A biotechnology company is seeking an experienced Clinical Development Consultant to help shape the clinical strategy and execution roadmap for its lead Immunology & Inflammation (I&I) program as it advances from preclinical development into early-stage clinical trials.

Working closely with executive leadership and scientific teams, this consultant will play a key role in defining clinical strategy, designing early-phase development plans, and supporting regulatory readiness.

The Role

The company is seeking a Clinical Development Consultant to provide strategic leadership for its lead Immunology & Inflammation program.

The consultant will lead clinical development planning from the preclinical transition through Phase 1 and Phase 2 studies while collaborating with scientific leadership, regulatory stakeholders, and external key opinion leaders to position the program for successful clinical advancement.

Key Responsibilities

Clinical Development Strategy

• Lead the clinical development strategy for the company's lead Immunology & Inflammation asset.
• Guide the transition from preclinical development into early-stage clinical trials.
• Develop the overall clinical roadmap through Phase 1 and Phase 2 development.

Clinical Program Design

• Design Phase 1 and Phase 2 clinical development plans and study protocols.
• Provide strategic guidance on translational medicine and biomarker strategies.
• Advise on patient selection criteria and clinical endpoints.
• Support indication prioritization across autoimmune disease programs.

Scientific & Cross-Functional Leadership

• Collaborate with internal scientific leadership and external Key Opinion Leaders (KOLs).
• Help define target product profiles and clinical differentiation strategies.
• Serve as a scientific advisor to executive leadership throughout program development.

Regulatory & Competitive Strategy

• Support regulatory strategy development for early clinical programs.
• Contribute to interactions with health authorities.
• Evaluate competitive clinical landscapes and emerging therapeutic trends within immunology and autoimmune diseases.
• Identify regulatory risks and strategic opportunities throughout clinical development.

Qualifications

Required Experience

• MD or MD/PhD.
• Background in rheumatology, immunology, or related autoimmune disease specialties.
• Experience serving as a Clinical Development Lead or equivalent within a biotechnology or pharmaceutical company.
• Demonstrated experience designing and advancing Phase 1 and/or Phase 2 clinical programs.
• Strong understanding of clinical development strategy for immunology and autoimmune disease therapies.
• Experience collaborating across scientific, clinical, and executive leadership teams.

Preferred Experience

• Experience supporting regulatory interactions for early-stage development programs.
• Expertise in translational medicine and biomarker strategy.
• Experience developing target product profiles and clinical differentiation strategies.
• Familiarity with competitive landscape analysis within Immunology & Inflammation.

Compensation & Benefits

• Fractional, on-demand consulting engagement
• Opportunity to influence the clinical strategy of an innovative biotechnology program
• High-impact executive consulting role with direct exposure to senior scientific leadership
• Opportunity to shape early clinical development, regulatory strategy, and long-term product vision
• Flexible remote consulting engagement

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