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 Sr. Manager of Clinical Pharmacology will be based in South San Francisco and report to the Senior Director, Head of Clinical Pharmacology. He/she will be responsible for the development of the strategic, scientific, translational and clinical development aspects of clinical pharmacology development plans across multiple indications. He/she will define key milestones and decisions, identify risks and mitigation strategies, provide input to modeling and simulation plans and the interpretation of pharmacokinetic/pharmacodynamic data from Phase 1 to 4 studies.

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

Responsibilities

  • Provide clinical pharmacologist support for Phase 1 studies including first-in-man, biopharmaceutics, drug-drug interactions, special populations, and proof-of-pharmacology/concept studies, and be accountable for timely and high-quality execution of all clinical studies under his/her responsibility in the Pliant Portfolio.
  • Support project team meetings, seek input from and ensure alignment with cross-functional partners, consultants, experts and vendors, as needed.
  • Contribute to develop clinical pharmacology sections of clinical and regulatory documents including clinical protocols and study reports, statistical analysis plans, IND and IMPD submissions, regulatory briefing documents, pediatric investigational plans, NDA and/or MAA submissions, and represent clinical pharmacology during regulatory interactions.
  • Work in close cross-functional collaboration with Clinical Operations, Regulatory Affairs, Program Management, Quality Assurance, Biometrics and Data Management, Pharmacovigilance and Clinical Research Organizations (CROs).
  • Support clinical pharmacology studies with varying degrees of complexity.
  • Represent the clinical pharmacology function and provide subject matter expertise on cross-functional project teams, including the study execution team (SET) and the clinical study team (CST).
  • Develop high-quality clinical pharmacology plans and author related content for global regulatory submissions, including INDs, IMPDs, CTAs, IBs, NDAs, MAAs and pediatric investigational plans.
  • Provide scientific input into the study rationale and design, author/review/approve clinical protocols and statistical analysis plans, interpret pharmacokinetic and pharmacodynamic data for study reports and regulatory submissions.
  • Establish and develop working relationships with contract research organizations and bioanalytic vendors and provide clinical pharmacology oversight.
  • Identify, develop, and manage vendors for population PK, PK/PD, and PBPK modeling.
  • Ensure that Phase 1 clinical studies are conducted in compliance to GCP, company SOPs, governing laws, and regulations.
  • Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
  • Identify and implement clinical pharmacology tools and technologies to drive smarter drug development for programs.
  • Attend meetings with external stakeholders (investigator meetings, clinical/scientific advisory boards) and health authorities, as needed.

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.

  • PhD degree in pharmaceutics, pharmacokinetics, pharmacology, or related discipline.
  • 4+ years of biotech/pharma drug development experience with deep expertise in clinical pharmacology.
  • Excellent working knowledge of clinical pharmacology (pharmacokinetics, pharmacodynamics, translational medicine) and drug development principles.
  • In depth knowledge of population PK, PK/PD, PBPK modeling concepts, data analysis, and interpretation with demonstrated record in applying these concepts to support clinical development programs.
  • Strong understanding of modeling and simulation.
  • Experience with pharmacokinetics for small molecules.
  • Track record of formulating, integrating and translating clinical pharmacology strategies into actionable deliverables.
  • Direct experience leveraging modeling and simulation to facilitate compound development and registration with a sound understanding of the technical aspects of modeling and available software (e.g., NONMEM, WinNonLin, S-Plus/R, etc.) used for analysis.
  • Strive for continuous improvement and embrace innovative ideas in daily work.
  • Good working knowledge of FDA, EMA and ICH regulations and ability to incorporate relevant regulatory requirements into development plans, study design and ensure adherence to regulations, including GCP requirements during study conduct.
  • Regulatory experience (i.e., INDs, NDAs, BLAs, etc. submissions, responses to Health Authority queries, direct interaction with Healthy Authorities).
  • High degree of organizational awareness, ability to connect the dots to understand the interdependencies and see the big picture.
  • Ability to interpret and communicate complex scientific concepts in a concise and clear manner to an audience with various levels of expertise to ensure scientific input is incorporated into strategic decision-making.

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 $180K – $190K. 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.