Associate Director, Clinical Operations at Dispatch Bio | CA | Rezi

Associate Director, Clinical Operations at Dispatch Bio

Associate Director, Clinical Operations

Dispatch Bio · CA

2 weeks ago

Associate Director, Clinical Operations

Dispatch Bio · CA

18 days ago
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About the Role

The Associate Director, Clinical Operations will be responsible for the planning, execution, and oversight of early-phase (Phase I/II) oncology clinical trials. This role involves close collaboration with internal departments and external vendors to ensure studies meet high standards of quality, timeliness, and regulatory compliance.

Responsibilities

  • Lead the operational execution of early-phase (Phase I/II) oncology clinical trials from start-up to close-out.
  • Serve as the primary operational point of contact for CROs, vendors, and investigative sites, ensuring timely and quality deliverables within budget.
  • Develop and manage study timelines, budgets, and risk mitigation plans, proactively resolving issues.
  • Oversee site selection, activation, and ongoing site management in partnership with CROs and the Clinical Operations team.
  • Collaborate with Clinical Development and Biostatistics to develop and review study documents.
  • Manage vendor oversight activities for supporting vendors.
  • Partner with Drug Supply/CMC teams to ensure adequate investigational product supply and accurate forecasting.
  • Monitor trial enrollment, data quality, and safety reporting.
  • Contribute to the development of departmental SOPs, working practices, and process improvements.
  • Support inspection readiness activities and ensure trials comply with ICH-GCP, FDA regulations, and quality standards.
  • Prepare and present study status updates to internal stakeholders and senior leadership.

Requirements

  • Bachelor’s degree required; advanced degree (e.g., MS, RN, PharmD) in a life sciences or related field preferred.
  • Minimum of 7 years of progressive clinical operations experience in the biotechnology or pharmaceutical industry.
  • Demonstrated experience managing early-phase (Phase I/II) oncology clinical trials, including study start-up, site management, and vendor oversight.
  • Strong working knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial operational best practices.
  • Experience managing CROs and other third-party vendors, including budget and contract oversight.
  • Proficiency with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and other clinical trial software.
  • Collaborative nature, geared toward cross-functional teamwork.
  • Excellent organizational, problem-solving, and time management skills.
  • Positive attitude, dedicated work ethic, and flexible orientation for operating in a fast-paced, entrepreneurial environment.
  • Strong verbal and written communication skills.
  • Demonstrated leadership skills.
  • Ability to be onsite 4 days per week.
  • Ability to travel up to 20%, if needed.

Skills

  • Clinical trial management systems (CTMS)
  • Electronic data capture (EDC) platforms
  • ICH-GCP guidelines
  • FDA regulations
  • Leadership
  • Organizational skills
  • Problem-solving
  • Time management
  • Communication skills
  • Cell and gene therapy (preferred)
  • Personalized medicine (preferred)
  • Biologics clinical trials (preferred)
  • Regulatory submissions (preferred)
  • Inspection readiness activities (preferred)

Location

  • Onsite 4 days per week

Work Type

  • Full-time
  • Hybrid

Experience Level

  • Associate Director
  • 7+ years of experience

Education Level

  • Bachelor's degree
  • Advanced degree preferred (MS, RN, PharmD)

Benefits

  • Highly competitive compensation package
  • Meaningful ownership through equity
  • Excellent medical, vision, and dental coverage
  • 401(k) with generous contribution
  • Life insurance
  • Flexible PTO policy
  • Additional substantial benefits

About the Company

  • Dispatch aims to create a world where all cancer patients can be cured by engineering a universal treatment across solid tumors.
  • The company leverages first-in-class technologies in viral vectors, universal targets, and novel cytokine biology.
  • Founded on pioneering work from leading researchers, Dispatch is dedicated to scientific rigor, an ownership mindset, and collaboration.
  • The company fosters a culture of delivering with urgency and sharing feedback to achieve its vision.

Equal Opportunity

  • We are an equal opportunity employer.
  • We do not discriminate on the basis of race, religion, gender, sexual orientation, age, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.