Director, Document and Training Management
Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.
The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.
Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.
Description
Pliant Therapeutics is currently seeking a seasoned industry leader to join our team as Director, Document and Training Management. This role will provide strong leadership and strategic planning in support of client functions within the organization.
To be successful in this role, you must be able to establish vision and guidance to the GxP personnel, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. This will require the ability to develop and administer quality systems in regard to document management and personnel training and qualification, including electronic quality system processes utilizing phase appropriate principles. Additionally, the successful candidate will create an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.
This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).
Responsibilities
- Responsible for direction and control of the site Document Management quality system, including Veeva document management (in Veeva QualityDocs and hard copy) program, processes, procedures, system administration and training.
- Collaborate cross functionally to implement, oversee, and improve workflows for document management and personnel training.
- Set, track, and trend site related Quality Metrics.
- Business Process Owner for Veeva QualityDocs to drive quality improvements by designing, supporting, and improving GxP documentation management, including organization support for operation, use, administration, change ownership for Veeva QualityDocs for improvement and compliance.
- Responsible for implementation and ownership of the site GxP training program (in Veeva Vault), processes, procedures, system administration and training including:
- Refinement and execution of the personnel training and qualification program, including the support of functional areas in designing and execution of training, as well as establishing, monitoring, and reporting of training key performance indicators.
- Supporting ongoing implementation and improvement of the training assessment process and requirements such as quizzes and other written assessments, establishing and supporting on-the-job training guidelines and criteria using phase appropriate requirements.
- Supporting site inspection readiness program.
- Other duties as assigned
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.
- Minimum 12+ years of relevant industry experience, ideally in all clinical phases through commercialization and a degree in pertinent life sciences
- Experience in managing GxP document management and training systems
- Strong knowledge of cGMP/ICH/FDA/EU requirements. Ability to assess compliance of regulations and industry standards.
- Strong understanding of ICH, FDA, and EU regulations
- Exercise sound judgement in ensuring that written procedures are followed with proven ability in driving quality process improvement initiatives
- Independently motivated, detail oriented and good problem-solving ability
- Excellent communication skills, both oral and written to clearly and concisely communicate with internal and external team members
- Excellent interpersonal skills and ability to effectively collaborate in a dynamic project team environment
- Proficient computer skills required with experience using Microsoft Word, Excel, and PowerPoint
- Veeva experience required
The annual base salary for this role is $220K – $230K. 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.
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/.
