Description
Reporting to the SVP of Development Operations, the Senior Director, Clinical Operations is responsible for the implementation and management of functional processes, tools and resources to enable delivery of Pliant's clinical programs with excellence. The Sr. Director will collaborate closely with a cross-functional team in a fast-paced, high-growth environment to ensure all clinical trials in the portfolio are executed on time, within budget, and in accordance with applicable GCP/ICH guidelines, other regulatory requirements and the corporate goals and objectives. The Sr. Director will also provide leadership to the Clinical Operations function, serving as a functional lead in cross-functional environments, and accountable for organizational initiatives.
This is a hybrid role based in South San Francisco (3 days onsite per week).
Responsibilities
- Accountable for the comprehensive oversight and management of all clinical studies in the portfolio, including providing strategic and tactical guidance to study teams to ensure timely operational execution and completion of clinical trials.
- Accountable for ensuring and maintaining ICH/GCP compliance and inspection-readiness across clinical programs.
- Develop and manage the resourcing plan for Clinical Operations including the assignment and allocations to clinical studies and leading the hiring of new team members, as needed.
- Accountable for developing detailed clinical program budgets and managing spend in accordance with plans.
- Coach and manage multiple direct reports; and mentor junior members of the team.
- Provide oversight of clinical research organizations (CROs) and other key vendors to ensure efficient, effective, and high-quality deliverables.
- Serve as the primary escalation point for issues related to operational execution and risk mitigation.
- Oversee the development of vendor specifications, project scope, and accountable for vendor selection.
- Oversee the establishment of KPIs, KRIs and stage-appropriate governance structures to drive and measure vendor performance.
- Oversee set-up and implementation of effective investigator and site training; facilitate compliance and program-related training for internal and external study team members as appropriate.
- Lead, participate, and/or contribute to the overall Clinical Development Plan as needed, including but not limited to the forecasting of study timelines, feasibility, country selections, and estimated budget.
- Oversee the review of study invoices and participate in accrual reviews to monitor and track the financial status of the study in relation to the budget.
- Prepare and present at senior management meetings, as needed, under the guidance of SVP, Development Operations.
- Accountable for establishing clinical operations SOPs, Work Instructions, guidelines, standards, related QS documents, and best practices.
- Lead and/or sponsor infrastructure initiatives, process improvements and enhancements, change management, and ad hoc business projects.
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
- Bachelor’s degree required with 15+ years of global clinical operations experience, including oversight and management of large global clinical trials through CRO partnerships (or equivalent combination of higher education, training and experience).
- 8+ years of people leadership experience with demonstrated success in building, coaching, and leading high-performing teams.
- Oncology or rare disease experience is a plus.
- Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and best practices.
- Deep experience with clinical operations systems, processes, and vendor management models.
- Exceptional organizational and prioritization skills with strong attention to detail, coupled with ability to maintain strategic, enterprise level perspective.
- Effective communicator with the ability to influence and engage internal and external stakeholders at all levels, including senior leadership.
- Proven ability to think strategically while driving disciplined execution.
- Demonstrated critical and creative thinking, resourcefulness and initiative, and problem-solving skills.
- Proven ability to work independently and interdependently while exercising initiative, adaptability, and sound judgment.
- Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel.
- Commitment to operating in alignment with Pliant’s values and culture.
How you work
- Dare to Succeed: Drive innovation across clinical programs by challenging traditional operating models, advancing new approaches to trial execution, and continuously improving operational efficiency and quality.
- Make an Impact: Take full accountability for program delivery, proactively identifying risks, accelerating decision-making, and ensuring clinical trials are executed on time, within budget, and with excellence.
- One Pliant: Lead cross-functional alignment and collaboration, integrating diverse expertise across teams and partners to ensure seamless execution and successful delivery of clinical programs.
