Job Title: Associate Director, Clinical Operations
Department: R&D: Clinical
Reports To: Vice President and Head of Operations
FLSA Status: Exempt
Location: San Diego or Remote
Reporting directly to the Vice President and Head of Operations, the Associate Director (AD), Clinical Operations will lead the planning, execution, and completion of regional/global clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines. The individual selected for this role will be the key leader in driving a cross-functional clinical trial team to execute on regional/global clinical trials through partnering and collaboration with internal and external team members.
- Responsible for the clinical operational oversight on Longboard’s clinical studies/program and lead the clinical operations team in successful trial conduct while ensuring the trial is conducted according to patient safety requirements, corporate timelines and budget
- Responsible to lead the cross-functional team in successful trial conduct while ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines
- Drives the completion of all study-related materials and systems according to timelines and industry standards
- Interacts and develops relationships with key opinion leaders, potential/selected investigators, and other key experts through attendance at sites, therapeutic conferences, and study investigator meetings
- Responsible for the overall management and oversight of CROs and third-party vendors to ensure compliance is adhered to by their SOPs and applicable regulatory guidelines
- Responsible for SOP gap analysis for CROs and internal processes and to develop mitigation plans to ensure oversight and compliance are of high quality
- Responsible for the development and training of materials related to the clinical trial Responsible for oversight of study budget, investigator and vendor contracts, budgets, and payments; completes accruals on a regular basis
- Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues, risks and mitigation plans to management in a timely manner
- Responsible for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready
- Develop and drive aggressive recruitment strategies, developing slides and presenting as needed for the cross-functional program teams and Longboard leadership
- Interacts with and participates in strategy discussions with other functional areas in the development of the protocol and other clinical trial activities with key stakeholders, including Clinical Development, Data Management, Biostatistics, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs)
- Responsible for the set-up and review of protocol data related activities during the conduct of the study such as deviation listing reviews and meetings, table, figure, data listings and clinical study report reviews
- Participates in the selection and oversight of Contract Research Organizations (CROs) and vendors
- Appropriately manage trial risks and required escalations and Partner effectively with CROs, vendors, investigators, and key stakeholders
- May have functional reporting responsibilities or indirect reports (e.g., clinical operation team members)
- Assists with clinical operations process development, innovative problem solving and training initiatives
- Other duties as assigned.
- Bachelor’s degree (Required)
- 8+ years of relevant and progressive clinical trial management experience across the full-cycle of drug development (Phase 1 through Phase 3)
- Preferred experience working on clinical development programs for neurological indications including developmental and/or epileptic encephalopathies (DEEs) and other seizure disorders,
- Preferred experience in FDA or other competent authority audit
- Preferred experience with internal study and site audits
- Experience with bio-samples, storage of 3rd party data
- Leadership excellence as a member of a cross-functional, global clinical trial team
- Advanced understanding in the management and monitoring of CRO and investigative sites
- Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management
- Advanced experience utilizing CTMS, EDC, TMF and related systems and software
- Broad knowledge of ICH, GCP, IRB/IEC and local & global regulatory authority drug research & development regulations
- Collaboration, teamwork, and passion for excellence in clinical operations
- Motivated to work in a fast-paced, high accountability environment
- Demonstrated ability to organize multiple priorities and projects, and to deliver high-quality work according to tight timelines.
- Demonstrates sound judgment and leadership skills.
- Demonstrates strong facilitation and interpersonal skills.
- Detail-oriented with effective problem-solving and troubleshooting skills.
- Process-oriented with the ability to understand complex data and information.
- Travel up to 20% (US and International)