Jobs and Careers
VA
Director, Clinical Operations
VaxcyteSan Carlos, United Statesfull_timeVerifiedPosted 6 Jan 2025
💰 $247,000/yr($233,000/yr – $247,000/yr)
About the role
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary:
The Director, Clinical Operations is a leadership role responsible for initiating and leading high priority vaccine clinical programs, inclusive of studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies through all phases of clinical trials (Phase I-III). The Director will be a leader in the organization who knows how to manage a team internally, at our clinical sites, and with our vendors. Will contribute to a high functioning mission driven team that is focused on patient safety, adherence to timelines and contracted deliverables, protocols, regulations, and data integrity.
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary:
The Director, Clinical Operations is a leadership role responsible for initiating and leading high priority vaccine clinical programs, inclusive of studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies through all phases of clinical trials (Phase I-III). The Director will be a leader in the organization who knows how to manage a team internally, at our clinical sites, and with our vendors. Will contribute to a high functioning mission driven team that is focused on patient safety, adherence to timelines and contracted deliverables, protocols, regulations, and data integrity.
Essential Functions:
- Lead and oversee the strategic planning, implementation and execution of clinical trials across key vaccine programs in accordance with project timelines, budget, and quality standards.
- Implementation of clinical strategy including site selection, study start up, authoring/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal functions and external vendors, anticipating and mitigating risks within the timeline, quality, and study budget.
- Collaborate with Clinical Outsourcing team for evaluation and selection of CROs/vendors, including ongoing management to ensure successful clinical trial implementation and execution. In addition, collaborating with Legal to review contracts and amendments for CROs/vendors, and support negotiations of terms and budgets if needed.
- Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies.
- Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Clinical Data Management, Clinical Supplies, Manufacturing, Clinical Outsourcing and Program Leadership to ensure alignment on clinical trial objectives and milestones in accordance with state/federal regulations, GCP, ICH and internal SOPs.
- Clinical QC: Support the development of quality control processes and study plans to ensure that clinical activities are compliant with GCP and regulatory guidelines. Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant policies and regulations.
- Supply Chain Management: Liaise with the supply chain function for supply of vaccines to clinical sites.
- Clinical Study Execution: Management of all clinical operations support vendors contracted for the assigned studies, including budgets and timelines oversight, performance management, risk management, and issue resolution.
- Clinical Study Team Meetings: Lead team meetings, as assigned, both internally and with multiple vendors. Attend project team and/or Executive team meetings, as required.
- Clinical Study Site Management: Cultivate and maintain strong relationships with investigators and trial site administrators. Organize investigator meetings as needed and contribute to the development of abstracts, presentations, and manuscripts for studies. Serve as the point of contact for Executive Governance
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s