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

 

Reporting to the SVP and Head of Clinical Development, the Senior Director will lead early-stage clinical development and strategy for new drug candidates, spanning across multiple therapeutic areas and new indications including immuno-oncology. The Senior Director will be responsible for the clinical development of PLN-101095, a small molecule currently in Phase 1 that is inhibiting αvβ8 and αvβ1 integrins expressed in the tumor microenvironment of patients with solid tumors resistant to immune checkpoint inhibitors. In this and other emerging programs, the Senior Director will assume a hands-on role in the design, planning, implementation, conduct and oversight of first-in-human and early-stage clinical trials in close partnership with Nonclinical, Biology and Translational Sciences, Regulatory Affairs, Clinical Operations and Program Management. The Senior Director will lead the drafting of clinical sections of INDs through cross-functional collaboration, ensure the proper clinical conduct of study protocols in compliance with GCP and local/global trial regulations, oversee and provide clinical guidance to CRO medical monitors (and study investigators, as needed) and study team. The Senior Director will work in close collaboration with cross-functional teams to develop the clinical strategy and achieve the clinical development goals and deliverables for assigned programs.

The candidate must have relevant and direct experience in drug discovery and early-stage clinical development (Phases 1 and 2) within the pharmaceutical and/or biotech industry (minimum of 4 years) including experience in oncology and is expected to be on site in South San Francisco at least three days per week.

 

Responsibilities

 

  • Drive the clinical development of Pliant’s oncology asset, PLN-101095
  • Lead the immuno-oncology clinical sub-team and drive the timely and high-quality execution of PLN-101095 as well as other upcoming early assets and programs within the portfolio
  • Participate in the ongoing review of clinical study data for PLN-101095, represent the Sponsor at Safety Review Committee meetings and participate in Pliant bi-weekly Safety Review Meetings, provide scientific oversight of CSR authoring, and prepare data for presentation at scientific/medical meetings as well as for abstracts and peer-reviewed publications
  • Develop early-stage clinical strategies and identify significant opportunities for differentiation of Pliant drug candidates, based on unmet needs and therapeutic landscape
  • Led clinical advisory boards as needed to advance early stage assets including in oncology
  • Be accountable for creating a detailed and state of the art global clinical development plan for PLN-101095 and other drug candidates, from pre-IND to Phase 2a, as needed across multiple indications
  • Lead the drafting of the clinical sections of INDs in close collaboration with Nonclinical, Biology and Translational Sciences, Regulatory Affairs, Clinical Operations and Program Management
  • Ensure that scientific rigor and innovation continues to be integrated into all early-stage programs and drives all early-stage clinical development strategies
  • Build and maintain relationships with key opinion leaders globally to identify new opportunities, obtain strategic guidance (including via scientific or clinical advisory boards) and develop study concepts into state-of the-art and workable study protocols
  • Work in close collaboration with Clinical Operations and designated CROs and Medical Monitors to ensure quality and timely execution of the clinical programs (i.e.: study startup, conduct and database lock activities; medical monitor training and oversight; safety monitoring plans; protocol deviation lists; data and AE coding reviews; statistical analysis plans; develop/present clinical slides at Investigators Meetings)
  • Draft/review/edit clinical study reports, investigator brochures and clinical aspects of regulatory submissions and clinical trial applications; supports all other regulatory activities, including protocol-related questions from health authorities
  • Ensure compliance to GCP, meet all statutory requirements and internal company policies and standard operating procedures
  • Support Business Development activities by providing clinical input, technical expertise, and drafting early development plans for Pliant’s pre-clinical programs
  • Collaborate with Biology and Translational Sciences and Clinical Pharmacology to provide clinical support and guidance for translational studies or develop translational components for early-stage trials
  • Domestic and global travel may be required

 

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.

  • Advanced degree in a health science related field (MD, PhD, PharmD) with a minimum of 4 years’ experience in the biotech/pharma industry
  • Experience in the drafting of INDs and the management and execution of first-in-human and early-stage clinical trials including oncology trials (experience in solid tumors strongly preferred)
  • Experience in fibrosis, muscular dystrophies and/or rare diseases is a definite plus
  • Sound and comprehensive knowledge of the drug development process, trial management and vendor oversight, safety reporting, MedDRA and WHODrug dictionaries, study methodology, data reviews, statistical analysis plans and local and global clinical trial regulations
  • High scientific acumen and demonstrated ability to independently evaluate, interpret and present complex scientific data
  • Sound understanding of statistics and demonstrated ability to critically evaluate complex drug development programs
  • Demonstrated ability to work collaboratively with a multi-disciplinary team of peers, consultants and vendors
  • Excellent communication skills including written, oral, and presentation skills. Evidence of publication of original scientific papers in translational and/or clinical research will be valued
  • Able to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet stretch goals
  • Strong people management skills that focus on teamwork and building alliances; ability to resolve conflicts and to negotiate effectively
  • Positive approach to work and ability to motivate team members to meet timelines and project goals is required
  • Ability to develop strong relationships with study investigators and key opinion leaders within a given therapeutic area

 

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 $270,000 - $280,000. 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/

Apply for this Job

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


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.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, 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?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

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.