Sr. Director, Clinical Operations
4 weeks ago
We are looking for a Sr. Director, Clinical Operations to join our growing South San Francisco team
The Sr. Director, Clinical Operations will support the Vice President Clinical Operations in overseeing the planning, execution, reporting, and tracking of clinical research studies at Vaxart. More specifically, the Sr. Director, Clinical Operations is the appointed Deputy Director or second in command with the authority to act as a substitute or on behalf of the VP Clinical Operations as needed and directed. This functional leadership role requires strong industry knowledge and experience in the management of clinical trials from clinical development conception to publishing clinical study reports. The successful candidate is accountable for outsourcing activities such as vendor selection and management, particularly of CRO’s, field sites, and clinical monitors. The Sr. Director Clinical Operations will ensure research studies are completed on time, within budget, and in accordance with GCP guidelines and all applicable regulatory requirements. The ability to effectively establish procedures, build cross-functional partnerships, manage staff, mitigate risks, make decisions, hold oneself and others accountable and escalate issues is essential. This is a highly dynamic position requiring strong communication, collaboration, and facilitation skills to balance multiple priorities in a matrix/team-based organization and numerous external stakeholders.
Responsibilities:
Lead efforts in identifying, vetting, and selecting vendors for outsourced activities. Analyze resource allocation and draft budget estimates. Define strategy, operational tactics, and interdependent responsibilities for study team members. Coordinate and align clinical operations endeavors with study objectives and corporate goals. Develop study timelines in collaboration with various cross-functional teams such as project management, manufacturing, regulatory affairs, and analytics. Coordinate the development and/or review of essential study documents such as synopses, protocols, amendments, and clinical study reports. Develop and/or review study plans and site documents such as ICF, SMP, MMP, CMP, SAP, etc. Facilitate CRF development, participate in UAT of EDC, and oversee data management activities. Support the project management team in tracking deliverables and monitoring progress of interdependencies to adhere to study timelines and budgets. Assist the CMC and Analytics teams in the outsourcing strategy and management of drug depots and testing labs, respectively. Prepare and present study metrics to train and/or report trial status and progress to internal and external stakeholders. Hires and effectively manages a high performing team to achieve clinical goals on time and on budget. Coordinate activities for the timely and appropriate handling and management of reportable adverse events to, and with, CRO’s, clinical sites, medical monitors, pharmacovigilance personnel, regulatory authorities, and pertinent Vaxart staff. Collaborate with Medical Director and Regulatory Affairs to draft and/or review updates to necessary documents such as investigators’ brochure, INDs, and FDA correspondence as necessary and applicable. Identify, track, and escalate issues such as major or important protocol deviations, supply chain problems or concerns (including IP), timeline slippage, out of scope or over budget services, and study team staff matters. Review, analyze, and approve vendor quotes, purchase orders, and invoices. Report accruals and expenditures of pass-through costs to accounting. Assist legal counsel in the review of payment terms against study budget allocation and billable milestones. Ensure compliance with contract expectations and proper allocation of funds. Identify opportunities for process improvements and implement best practices in clinical trial management. Author and/or contribute to the development and refinement of clinical operations SOPs, work instructions, departmental and/or organizational policies, and other tools or documents. Support quality assurance and quality control activities. Ensures inspection readiness of study documents and vendorsRequirement:
Bachelor’s degree in a relevant field, e.g., Life Sciences, Business Administration, Project Management and 17 years of experience in clinical research, preferably in the biotechnology or pharmaceutical industry, or Master’s degree and 15 years of experience, or Doctorate degree and 12 years of experience Proven extensive leadership experience. Extensive knowledge of GCP, ICH guidelines, and FDA regulations. Ability to operate both strategically with executive stakeholders and colleagues and tactically when guiding study teams, strategic plans and key activities. Demonstrated understanding of regulations and guidelines governing clinical trial operations, including good clinical practice, clinical trial design and execution, the patient journey, clinical pharmacology, biostatistics, and clinical operations. Capable of communicating and collaborating with people of diverse backgrounds and job functions, with a demonstrated track record of collaborating with diverse stakeholders. Strong interpersonal skills that motivate others to excel and achieve their very best, including the ability to develop high-performing study teams. Proven ability to work with limited direction in a fast-paced, dynamic and goal-oriented environment. Must have strong organizational and time management skills with the ability to prioritize tasks effectively. Demonstrate excellent executive presence and aptitude to influence and manage change. Strong innovation, critical thinking, and troubleshooting capabilities. Computer literacy in software packages Microsoft Office applications and clinical research specific tools, e.g. Veeva and other database platforms.In accordance with California’s Pay Transparency law, Vaxart’s base salary range for this position is approximately $264,000 - $305,000 USD annually. The actual salary for this role will vary based on a variety of factors including education, job-related knowledge, and experience. This range does not include equity, benefits, bonuses, or other non-monetary compensation which may be included.
Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401(k) with employer matching, tuition assistance, and work-life balance.
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