Project Manager, Regulatory Compliance Specialist, Program ​/ Project Manager

We are partnered with a clinical-stage biotechnology company focused on advancing innovative biologics programs through early and mid-stage development. As the organization continues to scale, they are investing in and expanding their program management function to support clinical programs transitioning from Phase 1 into Phase 2. The company is well-capitalized, backed by leading pharmaceutical partners, and has strong financial support to advance its pipeline.

• Lead cross-functional program planning and execution for biologics assets progressing from Phase 1 into Phase 2 to Later phase and Commercialization
• Develop and manage integrated program timelines, ensuring alignment across all functional areas
• Coordinate with Clinical Operations, Clinical Development, Regulatory Affairs, CMC, and external partners (e.g., CROs, vendors)
• Drive program governance, including preparing materials for internal leadership reviews and decision-making forums
• Identify program risks and implement mitigation strategies to ensure successful execution
• Support clinical trial planning, including protocol development, study start-up, and execution readiness for Phase 2
• Facilitate communication across internal teams and external stakeholders to ensure transparency and alignment
• Track key milestones, deliverables, and budgets across the program lifecycle
• Assist in preparation of regulatory documents (e.g., IND amendments, briefing packages) in collaboration with Regulatory teams
• Ensure programs are executed in accordance with corporate strategy, timelines, and quality expectations

• Bachelor’s degree required; advanced degree (MS, PhD, or MBA) preferred
• 5–10+ years of experience in biotech or pharmaceutical industry, with a focus on clinical development and/or program management
• Demonstrated experience supporting or leading biologics programs from IND to Phase 3/BLA
• Strong understanding of clinical development processes, including early-phase trial design and execution
• Experience working in cross-functional teams within a fast-paced, clinical-stage biotech environment
• Proven ability to manage timelines, budgets, and multiple stakeholders simultaneously
• Excellent communication, organizational, and leadership skills
• Experience working with external vendors and CROs

• Background in oncology, immunology, or other complex biologics modalities
• Prior experience in a small-to-mid-sized biotech environment
• Exposure to regulatory interactions and early-phase development strategy