Clinical Development Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop the clinical development plan and first-in-human strategy.

• Create the Phase 1 protocol, detailing dose, endpoints, population, pharmacodynamic readouts, and operational execution.

• Formulate the translational and biomarker strategy for human proof-of-mechanism.

• Facilitate the path to IND and early regulatory strategy.

• Conduct Advisory Boards and generate decision-grade insights.

• Establish the KOL and site network in preparation for clinical trials.

• Connect with thought leaders, physicians, principal investigators, and patients regarding metabolism and autoimmune diseases.

• Contribute to the overarching platform narrative for investors and partners.

⛳️ Requirements

• MD, with qualifications that enhance both actual and perceived credibility for the program.

• Established and warm global KOL and site network in autoimmune diseases; a metabolic disease network is an advantage.

• Proven experience in advancing assets into the clinic and successfully managing complex first-in-human and early-phase programs.

• Direct experience in designing and executing early clinical development, especially proof-of-mechanism studies in immune-mediated diseases.

• Proficient in owning translational and pharmacodynamic strategy.

• Strong strategic and scientific judgment.

• Commitment to patient advocacy and a willingness to challenge conventional paradigms.

• Significant reputation within the clinical community.

• Entrepreneurial mindset, comfortable with ambiguity and building processes.

• Team-oriented, straightforward, and focused on execution.

🏝️ Benefits

• Medical, dental, and vision insurance covered at 90%.

• 401(k) plan with company matching.

• Flexible paid time off (PTO).

• Company-wide weeklong recharge break.

• Adoption assistance.