Arisan Therapeutics, Inc

Compensation

Full Description

Project Manager / Senior Project Manager – Clinical Antiviral Development (Phase 2 → NDA) We are a small, science‑driven biopharmaceutical company headquartered in coastal Carlsbad, CA advancing first‑in‑class preclinical and Phase 2 clinical development programs primarily through U.S. government‑funded support. We operate with the agility of a startup and the rigor required for global regulatory success. Every team member plays a direct role in shaping the program and accelerating delivery of urgently needed antiviral therapies. Position Summary We are seeking an experienced, highly organized full time Project Manager to lead our international Phase 2 clinical‑stage antiviral development program through NDA submission. This individual will serve as the operational anchor for a cross‑functional team spanning clinical development, CMC, regulatory affairs, biostatistics, safety, and external partners, and will have remote / on-site flexibility. The ideal candidate brings hands‑on experience managing government‑funded drug development or testing contracts, with a strong preference for Department of Defense programs (JPEO‑CBD, DTRA). Experience with BARDA or NIAID/NIH drug development contracts is also highly valued. Because our program includes global clinical execution, experience supporting international clinical trials is a significant advantage. Additional pluses would include experience supporting international antiviral or infectious disease clinical trials and familiarity with NDA structure, NDA Module 2/3/5 integration, and late‑stage development requirements. Key Responsibilities Program Leadership & Execution · Lead day‑to‑day project management for a clinical‑stage antiviral program progressing from Phase 2 through NDA. · Develop and maintain integrated project plans, timelines, budgets, and risk registers. · Drive cross‑functional alignment across Clinical Operations, CMC, Regulatory Affairs, Safety, Biostatistics, and external partners. · Support execution of international Phase 2/3 and ancillary US-based clinical studies, including coordination across regions, vendors, and regulatory environments. · Ensure timely delivery of CMC scale‑up, validation activities, and NDA‑enabling workstreams. Government Contract Management · Serve as the primary operational liaison for government‑funded activities with JPEO‑CBRN Medical. · Manage contract deliverables, milestone documentation, technical progress reports, and compliance obligations. · Coordinate government‑funded testing, manufacturing, or clinical support activities as applicable. Ensure alignment with government expectations for documentation, transparency, and audit readiness. Vendor & CRO Oversight · Manage relationships with CROs, CDMOs, clinical vendors, and government‑supported testing facilities. · Support clinical CRO management, including study initiation, execution, and delivery of high‑quality data packages across U.S. and international sites. · Track performance, budgets, and timelines; proactively escalate risk. Regulatory & NDA Support · Partner with Regulatory Affairs to support NDA planning, data QC, cross‑functional readiness, and submission execution. · Coordinate preparation for regulatory meetings (e.g., End‑of‑Phase 2, pre‑NDA). · Ensure clinical, CMC, and nonclinical data packages are delivered on time and in compliance with global regulatory expectations. Communication & Reporting · Serve as primary liaison with government and/or other project stakeholders. · Prepare and lead internal and external project updates, dashboards, and risk assessments with internal team members and government and other project stakeholders. · Lead regular team meetings, ensuring clear action items and accountability. · Deliver high‑quality written reports and presentations for government agencies and internal leadership. Qualifications Required · Bachelor’s degree in life sciences, engineering, or related field (advanced degree preferred). · 7+ years of project management experience in biotech/pharma. · Demonstrated experience managing government‑funded drug development or testing contracts, preferably with DoD (JPEO‑CBD, DTRA). · Strong understanding of clinical development workflows, CMC scale‑up, and regulatory pathways from Phase 2 through NDA. · Proven ability to manage complex timelines, budgets, and multi‑partner programs. · Exceptional communication, organization, and stakeholder‑management skills. · Comfortable working in a small, fast‑moving, resource‑lean environment, fostering accountability What We Offer · A central leadership role in shaping program strategy and execution from Phase 2 through NDA in a challenging global health / US defense medical countermeasure program · Collaborative, mission‑focused culture with scientific rigor and operational agility. · Remote / on-site flexibility · Competitive salary range of $160 -204k based on experience and qualifications · Health insurance coverage · 401k retirement savings plan with company matching · Paid time off and holidays Pay: $160,000.00 - $204,000.00 per year Benefits: • 401(k) • 401(k) matching • Health insurance • Paid time off Work Location: Remote