Associate Director, Clinical Development

Associate Director, Clinical Development

Location: Los Angeles, CA

About the Role

We are seeking an experienced and highly motivated Associate Director, Clinical Development to play a key role in advancing innovative clinical development programs from early-stage research through late-stage and potentially registrational studies. This individual will work closely with cross-functional teams to develop and execute clinical strategies, translate scientific and clinical data into actionable insights, and support the advancement of promising therapeutic candidates.

The ideal candidate will bring strong clinical development expertise, experience designing and conducting complex clinical trials, and a thorough understanding of U.S. FDA regulations and global clinical development requirements. This is an opportunity for a scientifically driven professional to make a meaningful contribution to the development of novel therapies while collaborating with medical, regulatory, safety, scientific, commercial, and external stakeholders.

Our Values

• Integrity – We operate with honesty, transparency, and accountability in everything we do.
• Intelligence – We apply scientific rigor, critical thinking, and sound judgment to solve complex challenges.
• Initiative – We take ownership, proactively identify opportunities, and move programs forward with urgency and purpose.

What You Will Do

• Lead the development and drafting of clinical trial protocols for new indications, ensuring alignment with clinical objectives, regulatory expectations, and overall development strategy.
• Contribute to the planning, design, and execution of clinical development programs across multiple phases, with particular emphasis on Phase 1b, Phase 2, and Phase 2/3 registrational studies.
• Partner closely with cross-functional and global teams to incorporate medical, regulatory, pharmacovigilance, scientific, commercial, market access, and value perspectives into clinical development strategies.
• Evaluate, interpret, and communicate clinical trial data and emerging evidence to support informed development and strategic decision-making.
• Prepare and deliver scientific presentations to internal and external stakeholders, including key opinion leaders, advisory boards, scientific conferences, and external committee meetings.
• Establish and maintain productive relationships with key opinion leaders and external clinical experts to support program development and scientific strategy.
• Identify and evaluate new clinical research opportunities that may strengthen existing programs or support future indications.
• Collaborate with regulatory and clinical operations teams to ensure clinical studies are designed and conducted in accordance with applicable regulations, guidelines, and Good Clinical Practice standards.
• Support regulatory interactions and contribute to the preparation of clinical documentation and regulatory submissions, including IND and BLA-related materials.
• Provide scientific and clinical leadership throughout the development lifecycle and help ensure that clinical programs remain aligned with organizational objectives and regulatory requirements.

What We Look For

• Several years of hands-on experience in clinical development, including the design, planning, and execution of clinical trials and the development of clinical protocols for U.S. FDA submission.
• Demonstrated experience conceptualizing, designing, and conducting complex global clinical trials across multiple phases of development.
• Strong understanding of late-stage and registrational clinical development, particularly Phase 1b, Phase 2, and Phase 2/3 studies .
• Comprehensive knowledge of Good Clinical Practice (GCP) , U.S. FDA regulations and guidance, and applicable international clinical development and regulatory requirements.
• Prior experience working with regulatory authorities and participating in regulatory interactions.
• Experience authoring or contributing substantially to regulatory submissions, including IND and/or BLA filings .
• Strong ability to analyze, interpret, and clearly communicate clinical data and scientific information to both technical and non-technical stakeholders.
• Demonstrated ability to work effectively across multidisciplinary and geographically distributed teams.
• Strong communication, scientific presentation, organizational, and project-management skills.
• Advanced scientific or medical degree such as MD (or equivalent), PhD, PharmD , or another relevant bachelor's or higher-level degree, depending on experience and qualifications.

About the Company

We are a biotechnology company focused on developing innovative therapies for patients with serious and life-threatening diseases. Our research and development efforts are centered on advancing novel therapeutic approaches designed to address significant unmet medical needs.

Our lead clinical program is focused on NXC-201 , a BCMA-targeted chimeric antigen receptor T-cell ( CAR-T ) therapy being evaluated for patients with relapsed or refractory AL Amyloidosis . The program incorporates a proprietary approach designed to reduce non-specific immune activation while enabling the immune system to recognize and eliminate the underlying source of toxic light chains.

NXC-201 is currently being evaluated in a U.S. multicenter clinical study for relapsed/refractory AL Amyloidosis, NEXICART-2 (NCT06097832) , which has a potentially registrational design. The program has received significant regulatory recognition, including Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA, as well as Orphan Drug Designation (ODD) from the FDA and the European Medicines Agency (EMA).

This role offers an exciting opportunity to join a mission-driven clinical development organization and contribute directly to the advancement of potentially transformative therapies for patients with serious diseases.