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Arisan Therapeutics, Inc
Project Manager / Senior Project Manager Nonclinical Antiviral Development (NIAID Funded Program)
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What they do
A Clinical Project Manager is responsible for planning and managing all aspects of a clinical trial, usually for an organization undertaking pharmacological drug testing.
$178,504 / year median in California
Job Description
Project Manager / Senior Project Manager
- Nonclinical Antiviral Development (NIAID Funded Program) Arisan Therapeutics, Inc Carlsbad, CA Job Details Full-time $145,000
- $189,000 a year 5 hours ago Benefits Stock options Paid holidays Relocation assistance Health insurance 401(k) Paid time off 401(k) matching Qualifications Teamwork Managing healthcare project budgets DoD experience Contract management experience in healthcare Schedule management Product development projects Pharmaceutical company experience Virology Organizational skills Chemistry, manufacturing & controls Managing projects Toxicology Project contract management Pharmaceutical research experience Project stakeholder communication Cross-functional communication Stakeholder management Full Job Description Project Manager / Senior Project Manager•Nonclinical Antiviral Development (NIAID‑Funded Program) We are a small, science‑driven biopharmaceutical company located in Carlsbad, CA, advancing first‑in‑class preclinical and Phase 2 clinical development programs primarily through U.
- Lead day-to-day project management for a small‑molecule antiviral program from post-discovery through IND and Phase 1.
- Develop and maintain integrated project plans, timelines, budgets, and risk registers.
- Drive cross-functional alignment across nonclinical, CMC, regulatory, and external collaborators.
- Ensure timely execution of studies supporting IND‑enabling packages (toxicology, safety pharmacology, ADME, virology, formulation, and manufacturing).
- Operate within a government contract framework, ensuring compliance with government contractual requirements. Government Contract Management
- Manage contract deliverables, reporting requirements, milestone documentation, and compliance obligations.
- Serve as primary operational liaison with
NIAID DMID
program staff and technical teams.- Coordinate government-funded testing through
NIAID/NIH
networks (e.g., antiviral screening, animal models, PK/PD studies).- Ensure alignment with FDA study compliance and expectations for documentation, transparency, and audit readiness. Vendor & CRO Oversight
- Manage relationships with CROs, CDMOs, academic collaborators, and government testing facilities.
- Support study initiation, execution, and delivery of high-quality data packages.
- Track performance, budgets, and timelines; escalate risks proactively. 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., pre‑IND, IND, and End‑of‑Phase 1).
- Ensure nonclinical, CMC, and clinical data packages are delivered on time and in compliance with contractual and global regulatory expectations. Communication & Reporting
- Prepare and lead internal and external project updates, dashboards, and risk assessments with internal team members and government and other project stakeholders.
- Serve as a liaison with the 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 medical field
- 7+ years of project management experience in biotech/CRO/pharma.
- Demonstrated experience managing biopharma or government-funded (NIH/NIAID, BARDA, DoD, or similar) drug development preclinical and/or clinical contracts .
- Strong understanding of nonclinical development workflows (toxicology, pharmacology, ADME, virology, CMC).
- 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. Preferred
- Experience conducting or managing IND-enabling studies and early clinical
- Experience with antiviral or infectious disease programs.
- Experience coordinating NIAID DMID-funded testing or development networks. What We Offer
- A central leadership role in shaping program strategy and execution through preclinical and IND-enabling studies, and initial human clinical studies in a global health / U.S. defense medical countermeasure program.
- Collaborative, mission-focused culture with scientific rigor and operational agility.
- Competitive salary range of $145,000
- $189,000 based on experience and qualifications.
- Company incentive stock option plan.
- Health insurance coverage.
- 401k retirement savings plan with company matching.
- Paid time off and holidays.
Pay:
$145,000.00- $189,000.