Senior Program 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. Key Responsibilities 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 Qualifications 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 Preferred Experience 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 #J-18808-Ljbffr Barrington James