pliant-therapeutic

Senior Director, Clinical Operations

South San Francisco, CA · Director · Full-time

Sponsorship not specified$289k-$320kDetected 63 days ago

GCPComplianceForecastingVendor ManagementClinical TrialsClinical ResearchResearchLeadershipCollaborationProblem SolvingMentoringAdaptabilityMicrosoft OfficeGxP

About the role

Pliant Therapeutics is a clinical-stage biopharmaceutical company and leader in the discovery and development of novel integrin-based therapeutics.
Integrins are a crucial link between a cell's internal structure and its external environment and function in cell signaling, regulation and adhesion as well as wound healing and immune response.
This is a hybrid role based in South San Francisco (3 days onsite per week).

Responsibilities

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
Oversee the establishment of KPIs, KRIs and stage-appropriate governance structures to drive and measure vendor performance.
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.
Coach and manage multiple direct reports; and mentor junior members of the team.
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.
Lead cross-functional alignment and collaboration, integrating diverse expertise across teams and partners to ensure seamless execution and successful delivery of clinical programs.
To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.

Requirements

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.
8+ years of people leadership experience with demonstrated success in building, coaching, and leading high-performing teams.
Deep experience with clinical operations systems, processes, and vendor management models.
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.
Proven ability to work independently and interdependently while exercising initiative, adaptability, and sound judgment.
Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel.
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).
Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and best practices.
Exceptional organizational and prioritization skills with strong attention to detail, coupled with ability to maintain strategic, enterprise level perspective.
Demonstrated critical and creative thinking, resourcefulness and initiative, and problem-solving skills.
Commitment to operating in alignment with Pliant's values and culture.
How you work

Nice to have

Oncology or rare disease experience is a plus.

Compensation

The annual base salary for this role is $289K - $320K.

Benefits

Pliant's compensation package also includes benefits, equity, and annual target bonus for fulltime positions.
Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training.

Visa & Work Authorization

Lead and/or sponsor infrastructure initiatives, process improvements and enhancements, change management, and ad hoc business projects

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