Position Summary

We are seeking a highly accomplished and visionary Senior Clinical Development Leader (up to VP level) to drive our clinical development strategy in solid organ transplantation (SOT). The ideal candidate will bring deep and respected clinical expertise in SOT, with expert knowledge in immunosuppressive therapies to prevent & treat organ rejection and proven success in designing and executing innovative Phase 2 and 3 clinical trials. This leader will play a pivotal role in advancing our trusted immunotherapy platform in the SOT space through clinical development, regulatory approval, and ultimately to patients in need.

Key Responsibilities

• Clinical Strategy & Leadership

o Define and lead the clinical development strategy for SOT programs for our trusted immunotherapy platform. 

o Serve as the clinical thought leader for SOT within the company, shaping both near- and long-term development plans.

o Act as a key clinical voice in the SOT space internally and externally, including KOL engagement, advisory boards, and medical congresses.

• Clinical Trial Design & Execution

o Lead the design and execution of innovative, efficient, and patient-centric Phase 2 and 3 trials in SOT.

o Ensure clinical programs are aligned with regulatory strategy, commercial goals, and scientific advancements.

o Collaborate with Clinical Operations and external partners to deliver high-quality trial execution in a fast-paced company.

• Regulatory Engagement & Innovation

o Partner with regulatory affairs to develop and implement innovative clinical trial designs and to be able to apply expedited regulatory pathways (e.g., Breakthrough, PRIME, RMAT).

o Represent the company in global regulatory interactions, providing authoritative clinical expertise in the SOT space.

• Cross-Functional Collaboration

o Collaborate closely with research, regulatory, clinical operations, and external alliance partners to maximize the impact of our SOT programs.

o Act as a senior member of the development leadership team, providing input into portfolio strategy and broader company direction.

Qualifications & Experience

• Clinical Expertise:

o Medical degree (MD or equivalent) with board certification and clinical experience in solid organ transplantation (nephrology, hepatology, cardiology, pulmonology, or related transplant medicine specialty).

o Deep understanding of current immunosuppressive therapies and clinical management of transplant patients.

• Drug Development Leadership:

o Proven track record of designing, leading, and executing successful Phase 2 and 3 clinical trials in transplantation or closely related therapeutic areas.

o Demonstrated experience in applying innovative trial designs that had achievedexpedited regulatory approvals in the US and/or EU.

o Strong familiarity with GCP, ICH guidelines, and global regulatory requirements.

• Biotech/Pharma Experience:

o Prior leadership experience in a fast-paced biotech or agile pharmaceutical company, ideally taking programs from early clinical through pivotal studies.

o Ability to thrive in a dynamic, entrepreneurial environment while maintaining a high sense of urgency and accountability.

• Leadership & Influence:

o Recognized as a respected clinician and thought leader within the transplant community.

o Exceptional communication, collaboration, and team leadership skills.

o “Can-do” mindset with the ability to balance strategic vision with hands-on execution.

What We Offer

• Opportunity to lead transformative programs in transplantation medicine.

• A fast-moving, innovative, and collaborative biotech culture.

• Competitive compensation, equity participation, and comprehensive benefits.