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

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