The role:The Associate Director, Clinical Operations will play a critical role in the planning, execution, and oversight of Dispatch's early-phase (Phase I/II) oncology clinical trials. Reporting to the Vice President of Clinical Operations, this person will partner closely with Clinical Development, Regulatory Affairs, Biostatistics, Drug Supply, and Quality Assurance internally, as well as with CROs, central labs, and other clinical trial vendors externally, to ensure our studies are executed with the highest standards of quality, timeliness, and regulatory compliance.
Key responsibilities:- Lead the operational execution of one or more early-phase (Phase I/II) oncology clinical trials, from study start-up through close-out
- Serve as the primary operational point of contact for CROs, vendors, and investigative sites, ensuring deliverables are met on time, within budget, and to quality standards
- Develop and manage study timelines, budgets, and risk mitigation plans; proactively identify and resolve issues that could impact trial timelines or data integrity
- Oversee site selection, activation, and ongoing site management activities in partnership with CROs and the broader Clinical Operations team
- Collaborate with Clinical Development and Biostatistics to develop and review protocols, informed consent forms, case report forms, and other essential study documents
- Manage vendor oversight activities, including central labs, IRT, imaging, and other specialty vendors supporting early-phase oncology trials
- Partner with Drug Supply/CMC teams to ensure adequate investigational product supply and accurate demand forecasting
- Monitor trial enrollment, data quality, and safety reporting in collaboration with Pharmacovigilance and Medical Monitoring
- Contribute to the development of departmental SOPs, working practices, and process improvements as Dispatch's clinical operations function scales
- Support inspection readiness activities and ensure trials are conducted in accordance with ICH-GCP, FDA regulations, and Dispatch quality standards
- Prepare and present study status updates to internal stakeholders and senior leadership
Required experience & skills:- 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, with the ability to translate complex clinical information for diverse audiences
- Demonstrated leadership skills, including the ability to manage a clinical operations team, communicate, coach, mentor, and develop employees
- Ability to be onsite 4 days per week
- Ability to travel up to 20%, if needed
Preferred experience & skills:- Experience with cell and gene therapy, personalized medicine, or other biologics clinical trials
- Prior experience working in a small or growth-stage biotech environment
- Experience supporting regulatory submissions (e.g., IND filings, IB updates) or inspection readiness activities
- Established relationships with CROs and vendors specializing in oncology and/or cell therapy trials
- People management experience, with a track record of developing and mentoring clinical operations staff
Our values: Our values guide everything we do. While capabilities and skills are vital, understanding how a potential new colleague would embody our values is central to our hiring decisions.
Determined to deliver: By working with focus and passion, we can provide patients with the solutions they need.
Own every outcome: We can reach new heights when we stay centered on our shared success.
Collaboration at the core: When we band together, our work is better.
Feedback is fundamental: Constructive and authentic positive feedback may be difficult to master but it is vital to our success.
Working here:- We offer a highly competitive compensation package with meaningful ownership through equity
- Excellent coverage for medical, vision, and dental
- 401(k) with generous contribution
- Life insurance
- Flexible PTO policy
- Additional substantial benefits
