We are an innovative, science-driven biotechnology company developing novel therapeutics across pulmonary diseases including COPD, with an expanding pipeline that extends beyond COPD into additional indications. Our team combines deep discovery and development expertise with a nimble, collaborative culture to advance small molecule programs from early research through late-stage clinical development.
Position Summary
We are seeking an experienced Program Manager to provide cross-functional leadership for a multi-indication small molecule program currently in Phase 2 clinical development. This role will initially be structured as a contractor engagement (heavy part-time), with the potential to transition into a full‑time employee role based on program progression. This individual will play a critical role in advancing the program beyond traditional functional silos, ensuring alignment across Clinical, Regulatory, CMC, and Supply Chain to enable efficient study execution. The Program Manager will be responsible for planning and scenario development in a dynamic environment, where future pathways include Phase 3 registrational studies and additional proof‑of‑concept (POC) trials as well as assuring alignment with early development/research and CMC efforts, all guided by emerging data from the internal and external environment.
Key Responsibilities
- Lead cross‑functional program management for a Phase 2 clinical‑stage small molecule program across multiple potential indications.
- Develop and maintain integrated development plans that account for multiple future scenarios, including Phase 3 registrational pathways and additional POC studies.
- Drive alignment across Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Supply Chain and Pre‑Clinical/Research teams to ensure seamless program execution.
- Oversee key operational elements supporting clinical studies, including site activation, drug supply logistics, and timelines.
- Partner closely with CMC and supply teams to ensure drug product readiness and availability for ongoing and future clinical trials.
- Facilitate cross‑functional decision‑making, proactively identifying risks and developing mitigation strategies in an evolving data environment.
- Ensure clear communication of program status, risks, and milestones to senior leadership.
- Break down functional silos to enable efficient execution across disciplines and geographies.
- Support governance processes and prepare materials for internal and external stakeholders.
Qualifications
- Bachelor’s degree required; advanced degree (MS, PhD, MBA, or equivalent) preferred.
- 10–15+ years of experience in program management or cross‑functional drug development roles within biotech or pharmaceutical companies.
- Demonstrated experience managing mid‑to‑late‑stage clinical development programs (Phase 2 and/or Phase 3).
- Strong understanding of end‑to‑end drug development, including Clinical, Regulatory, and CMC/supply considerations.
- Experience with small molecule development required; multi‑indication program experience strongly preferred.
- Proven ability to operate effectively in uncertain and evolving environments, including scenario planning and adaptive strategy development.
- Experience supporting clinical trial execution, including site activation and drug supply logistics.
- Excellent cross‑functional leadership, communication, and organizational skills.
- Ability to work independently in a contractor capacity while influencing without authority.
Engagement Model
- Initial engagement as a contractor (heavy part‑time) during the current Phase 2 stage.
- Anticipated transition to full‑time (FTE) based on program expansion, clinical readouts, and progression into Phase 3 and/or additional studies.
- High‑impact role with increasing scope aligned to pipeline growth.
Why Join Us
- Opportunity to shape and drive a high‑potential, multi‑indication program at a critical inflection point.
- Visible, high‑impact role working closely with senior leadership.
- Flexible engagement model with the potential to grow into a full‑time leadership position.
- Collaborative, entrepreneurial environment focused on advancing innovative therapies.