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

The Director of Clinical Development will be based in South San Francisco, report to the VP 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 Director of Clinical Development 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.

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

Responsibilities

  • Act as the Sponsor’s Medical Monitor in close collaboration with 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
  • 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)
  • Lead 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
  • 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
  • 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)

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 3-5 years of clinical research and development experience within pharmaceutical/biotech industry
  • Start-up/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 collaborative 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 $320K – $335K. 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/. 

Apply for this Job

* Required
resume chosen  
Dropbox
(File types: pdf, doc, docx, txt, rtf)
Cancel
cover_letter chosen  
Dropbox
(File types: pdf, doc, docx, txt, rtf)
Cancel

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Pliant Therapeutics, Inc.’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Enter the verification code sent to to confirm you are not a robot, then submit your application.

This application was flagged as potential bot traffic. To resubmit your application, turn off any VPNs, clear the browser's cache and cookies, or try another browser. If you still can't submit it, contact our support team through the help center.