Pliant Therapeutics is a public, clinical 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 disease. The Company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.
The Company’s lead product candidate, PLN-74809, is an oral, small molecule selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and are currently in Phase 2a clinical trials for these indications. The company recently reported positive data from its Phase 2a trial in IPF and is currently ramping up activities in preparation for a late-stage clinical trial at worldwide sites.
Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant is initiating 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.
The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.
Description
The Senior Director of Clinical Development will be based in South San Francisco, report to the SVP, Head of Clinical Development, act as Pliant’s Medical Monitor, and be accountable for timely and high-quality execution of all clinical studies under his/her responsibility in the Pliant Portfolio. He/she will work in close cross-functional collaboration with Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Program Management, Quality Assurance, Biometrics and Data Management, Pharmacovigilance and Clinical Research Organizations (CROs). The Medical Monitor is accountable for the safety of Pliant programs. The Senior Director will support early to late-stage clinical studies across multiple indications, deliver on state-of-the-art clinical plans that will create differentiation and significant value for Pliant, and build and develop strong working relationships with Principal Investigators and study sites to optimize study conduct and position the Company as a true partner of choice in the clinical research landscape.
Responsibilities
- Act as the Sponsor’s Medical Monitor across Pliant’s programs in close collaboration with the therapeutic-area specific clinical development leads, clinical operations and CROs, responsible for conducting clinical studies in compliance with the protocol, interacting with study investigators and responding to protocol/medical questions related to participant eligibility, concomitant medications, safety issues and toxicity management
- Lead regular safety review meetings for Pliant’s programs and is responsible for supervision of the CRO medical monitors for the respective programs.
- Support pharmacovigilance process; review individual data with Serious Adverse Events (SAEs) and important medical events; author and/or review all safety narratives and related regulatory reports (CIOMS, MedWatch)
- In charge of real-time safety surveillance of all clinical trials including oversight of the implementation and utilization of software to review core safety data
- Participate as a standing and/or ad hoc member in various clinical sub-teams (e.g., study execution team [SET], clinical study team [CST]) relevant to assigned molecule(s)/indication(s); support the CST lead with cross-functional integration, coordination, and alignment to enable effective and efficient clinical development plan execution
- Ensure that clinical study is conducted in compliance to GCP, company SOPs, governing laws, and regulations; review outstanding clinical or GCP issues, report and address issues across the study and, provide the study team with medical expertise during key activities
- Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
- Contribute to the design and development of clinical study protocols (Phases 1 to 3) from a concept sheet to a full protocol; participate in the review and finalization process with clinical operations, medical writing, regulatory affairs, clinical pharmacology, and other key cross-functional contributors
- In close collaboration with clinical operations, participate in the identification and selection of CROs, appropriate external investigators and sites
- Oversee and participate to protocol training, produce relevant training materials, and represent clinical development in Investigator meetings
- Coordinate with the study team to review and approve study processes and deliverables and participate in development of informed consent forms (ICF), case report forms (CRF), safety management plans, medical monitoring plans, statistical analysis plans (SAP) and clinical study reports (CSR)
- Participate in the development of clinical responses to protocol questions by healthy authorities, independent review boards and ethical committees, in collaboration with regulatory affairs and/or clinical operations
- Collaborate with clinical teams to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such
- Ensure that all clinical studies are conducted within timeline, budget, and quality specifications
- Review patient profiles, and study level data; review coding of adverse events (AEs), concomitant medications and protocol deviations
- In close collaboration with clinical operations, data management, biometrics and CRO, participate in all reviews and procedures required for database lock
- Review study data outputs to provide the most comprehensive clinical interpretation, for interim and final study reporting; develop topline study reports in collaboration with biometrics and relevant stakeholders (e.g., clinical pharmacology, translational sciences, etc.)
- Participate in the development and implementation of scientific communication and publication strategies for ongoing and completed studies.
- Engage with principal investigators and key opinion leaders at advisory boards, major medical meetings, congresses, and other scientific events
- Collaborate cross-functionally in development of clinical sections of investigator brochures (IB), annual safety reports, IND and IMPD updates
- Review of clinical data generated by data listings or statistical analyses outputs for assigned studies and, present findings at quarterly drug safety reviews, as needed
- Review literature as needed to address safety questions and interact with DSMBs and steering committees to present safety-related information
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.
- M.D. degree with at least 4 years of clinical research and development experience within pharmaceutical/biotech industry
- Previous experience as Medical Monitor in Phase 1-3 studies
- Experienced in MedDRA coding, review of concomitant medications and protocol deviations, safety reviews and use of safety monitoring software, signal detection, etc.
- Small company experience a plus; can-do attitude is essential
- Clinical development experience in an industry setting ranging from Phases 1 to 4, including first-in-human and pivotal studies
- Experience with rare diseases, fibrotic diseases in the liver (e.g., PSC, PBC, NASH) and/or lung (e.g., IPF, ILD, cystic fibrosis) is a plus
- Experience with development of clinical study related documents (e.g., clinical trial protocols, Investigator’s Brochures, clinical study reports)
- Knowledge of clinical trial methodology, statistics, regulatory and compliance requirements governing clinical trials, including GCP
- High integrity and the ability to bring out the best in others, intellectually and interpersonally
- Demonstrated strategic and critical thinking, dynamic leadership and team-building skills; as well as the ability to perform effectively in an adaptive environment
- Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills
- Able to facilitate discussions among groups with diverse technical expertise and varying opinions and drive decisions on complex issues
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 $290,000 - $312,000. 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/.
