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.
