Clinical Trials Project Manager and Regulatory Assistant

Clinical Project Manager and Regulatory Assistant

San Diego, CA - On- Site

$105,000 - $140,000

A clinical-stage biotech company in San Diego is seeking a Clinical Development Operations Lead to manage global clinical trials and support regulatory strategy across a diverse pipeline. This role is ideal for someone with a strong foundation in clinical research, regulatory coordination, and cross-functional leadership.

Key Responsibilities

• Clinical Trial Oversight: Lead the planning, execution, and closeout of global clinical studies, ensuring alignment with development and regulatory goals.
• Protocol & Site Management: Contribute to protocol design, site selection, and ongoing site relationships.
• Regulatory Support: Assist in the preparation of regulatory documents (e.g., INDs, briefing books, investigator brochures) and support health authority interactions.
• Cross-Functional Collaboration: Partner with internal teams across clinical operations, data management, medical affairs, and external vendors.
• Scientific Contribution: Review clinical data, support interpretation of results, and contribute to publications and presentations.
• Process Optimization: Participate in internal process improvement initiatives and mentor junior team members.
• Budget & Vendor Management: Develop and manage clinical trial budgets and oversee CROs and other external partners.

Qualifications

• Advanced degree in life sciences (PharmD, PhD, MS preferred).
• 5-7 years of clinical development experience in biotech or pharmaceutical settings.
• Proven track record in IND submissions and regulatory interactions.
• Experience in rare diseases, metabolic, CNS, or liver/kidney indications preferred.
• Familiarity with RNA-based platforms (siRNA, ASO) is a plus.
• Strong project management, communication, and leadership skills.
• Ability to work across time zones and manage international teams

This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.