Level: Executive Director / VP (depending on experience)

Reports to: Chief Medical Officer (CMO)

Location: USA - Remote

Position Overview

We are seeking an accomplished and visionary Senior Clinical Development Leader to drive our clinical development strategy and execution in the field of immunological disorders. This individual will be responsible for the design, oversight, and successful delivery of innovative Phase 2 and Phase 3 clinical trials and matching regulatory pathways to bring transformative immunomodulatory therapies to patients in need.

The ideal candidate will combine deep clinical and scientific expertise in immunology with a biotech mindset: entrepreneurial, decisive, and agile in fast-paced environments. Experience with innovative trial designs and regulatory pathways for expedited approvals (e.g., Breakthrough Designation, RMAT, EU PRIME) is essential. This position reports directly to the Chief Medical Officer.

Key Responsibilities

Strategic Leadership

• Define and lead the clinical development strategy for immunology assets end-to-end from Proof-of-Concept through pivotal studies and registration in various immunological conditions.
• Provide strategic medical leadership for cross-functional teams (Clinical Operations, Regulatory, Biometrics, Medical Affairs, Safety).
• Partner with senior executives on corporate strategy, portfolio prioritization, and go/no-go decisions.

Clinical Trial Design & Execution

• Design, oversee, and report innovative clinical trials (adaptive designs, enrichment strategies, real-world data integration).
• Ensure scientific rigor, operational excellence, and timely execution of Phase 2 and Phase 3 programs.
• Build and maintain strong relationships with KOLs, investigators, and advisory boards.

Regulatory & External Engagement

• Drive regulatory strategy in partnership with Regulatory Affairs, including engagement with FDA, EMA, PMDA and other health authorities.
• Successfully leverage expedited pathways (e.g., Fast Track, Breakthrough, EU PRIME) to accelerate development timelines and achieve expedited approvals.
• Represent the company in scientific and clinical forums, strengthening company visibility and reputation.

Team & Culture

• Mentor and inspire clinical development colleagues, fostering a high-performance, “can do” culture.
• Thrive in a fast-moving biotech-like environment, combining strategic vision with hands-on execution.
• Cultivate strong cross-functional collaboration and decision-making agility.

Qualifications & Experience

• MD (board certification in Immunology, Rheumatology or related specialty).
• 10+ years of industry experience in clinical development of agile companies with proven track record of successful delivery of Phase 2 and 3 immunology trials.
• Prior experience in a biotech or similar fast-paced environment is highly desirable.
• Demonstrated experience with innovative trial designs and novel regulatory pathways for expedited approvals.
• Strong leadership presence with the ability to influence at senior executive- and board level, demonstrating a business acumen.
• Excellent communication skills; ability to engage internal and external stakeholders effectively.

Personal Attributes

• Entrepreneurial mindset: flexible, adaptive, and thrives in uncertainty.
• Decisive and action-oriented: balances scientific rigor with speed of execution.
• Visionary yet hands-on: comfortable setting strategy while rolling up sleeves.
• Collaborative leader: empowers teams, builds trust, and drives accountability, providing a role model for junior clinical development colleagues

Why Join us?

• Opportunity to lead cutting-edge programs in various immunological disorders with high unmet medical need through a well-known, safe and effective platform.
• Be an essential part of a fast-moving, innovative biotech-like corporate culture with like-minded individuals.
• Senior, high visibility role reporting directly to the Chief Medical Officer.