Senior Director Clinical Project Management
Director / Senior Director, Clinical Program Operations
Remote (United States)
$175,000 - $215,000 base salary
Job Description
We are partnered with a late-stage, clinically focused biotechnology organization that is advancing multiple therapeutic programs addressing areas of high unmet medical need. The company is expanding its clinical development leadership team and is seeking a Director / Senior Director, Clinical Program Operations to oversee the operational execution of complex global clinical studies.
This role offers the opportunity to lead programs with meaningful clinical impact while working cross‑functionally in a fast‑paced, highly collaborative environment. The ideal candidate brings strong operational leadership, hands‑on trial execution experience, and a track record of successfully managing CROs and external partners across study phases.
Key Qualifications
* Extensive experience leading clinical trial operations within the pharmaceutical or biotechnology industry, including oversight of global clinical studies.
* Demonstrated success managing CROs, vendors, and external partners, ensuring delivery against timelines, budgets, and quality expectations.
* Strong understanding of ICH‑GCP, FDA, EMA, and other applicable global regulatory requirements.
* Proven ability to manage complex operational challenges related to patient enrollment, site performance, and protocol execution.
* Experience in metabolic disease or MASH highly preferred
* Experience developing and maintaining essential clinical documentation, including protocols, monitoring strategies, and operational plans.
* Ability to assess operational risks and implement proactive mitigation strategies across clinical programs.
* Excellent communication and leadership skills, with the ability to influence cross‑functional teams and executive stakeholders.
Roles & Responsibilities
* Lead the end‑to‑end operational execution of assigned clinical studies, from study start‑up through close‑out.
* Serve as the primary operational liaison with CROs and third‑party vendors, ensuring adherence to scope, timelines, and quality standards.
* Provide hands‑on oversight of day‑to‑day clinical operations activities, maintaining alignment with program goals and development strategy.
* Collaborate with internal functions including clinical development, regulatory, data management, safety, and quality to ensure seamless study execution.
* Oversee Trial Master File (TMF) strategy, ensuring inspection readiness and compliance throughout the study lifecycle.
* Identify, escalate, and resolve operational risks affecting enrollment, site performance, or data quality.
* Support continuous improvement initiatives within clinical operations, driving process efficiency and best practices.
* Contribute to strategic planning discussions related to future clinical programs and operational infrastructure.
Benefits
* Comprehensive medical, dental, and vision coverage
* 401(k) with company contribution
* Competitive PTO and paid holidays
FAQs
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