The Director is responsible for oversight of one or more of Pliant’s clinical programs to ensure completion per established project team goals and objectives.  The Director will report to the VP, Clinical Operations and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical trials are conducted on time and budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Accountable for the overall management of assigned clinical programs (across multiple studies), including providing strategic direction to study teams to ensure timely clinical trial execution.
• Responsible for maintaining inspection-readiness across clinical programs.
• Assist in development of hiring/resourcing plans and program budgets.
• Manage multiple direct reports.
• Mentor and oversee junior team members.
• Provide oversight of clinical research organizations (CROs) and other key vendors to ensure timely and quality deliverables.
• Provide a point of escalation for clinical trial execution issues.
• Lead preparation of vendor requirements and project scope and selection of study vendors.
• Responsible for clinical vendor selection.
• Contribute to the establishment of KPIs to measure vendor performance.
• Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data.
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results.
• Oversee set-up and implementation of effective investigator and site monitor training; facilitate operational and therapeutic area training for internal and external study team members.
• Review study invoices and participate in accrual reviews to track the financial status of the study against budget.
• Responsible for establishing clinical operations SOPs, Work Instructions, guidelines, standards, and best practices.
• Drive and implement infrastructure initiatives, process improvements, 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.
• 12+ years of experience working with CROs to manage large global clinical trials. Rare disease experience is a plus.
• 3+ years of experience managing direct reports, evidencing strong leadership, team-building, and hands-on management.
• Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices.
• Excellent organizational skills and attention to detail.
• Effective communication and interpersonal skills.
• Able to set priorities, juggle multiple demands, and manage changing priorities.
• Able to think critically and be a proactive problem-solver.
• Able to work independently while exercising initiative, flexibility, and sound judgment.
• Comfortable working with different levels of the company including senior level management.
• Ability to operate in alignment with Pliant’s values and culture.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $240K – $250K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.