Director, Clinical Outsourcing
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 is seeking a candidate with a proven ability to work collaboratively within a matrix environment to lead vendor outsourcing activities for the Clinical Development Organization (CDO). They will partner closely with the Head of Business Operations to implement new or improved processes, tools and strategies to enable effective outsourcing of services to vendor partners.
This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).
Responsibilities
- Proactively developing and maintaining the standards, processes and tools utilized by Business Operations.
- Leading the vendor selection lifecycle including Request-for-Information (RFI) and/or Request-for-Proposal (RFP) activities for clinical services such as study management (CROs), central laboratory, bioanalytical services, interactive response technology (IRT), etc.
- Leading the review and negotiation of budgets for CRO, central laboratory and other vendor agreements on behalf of Clinical Development.
- In collaboration with Legal, negotiating vendor agreements including payment terms in accordance with Pliant standards and processes.
- Developing site (investigator grant) budget templates in accordance with Pliant’s fair-market value standards.
- Supporting the quarterly financial reviews with Clinical Operations and Corporate Finance.
- Leading the budget forecasting activities for the Development organization during biannual Corporate budget planning cycles.
- Effectively partnering with relevant internal and external stakeholders such as Clinical Operations, Legal, Regulatory, Finance, Quality Assurance and/or vendors, as applicable, to enable informed, risk-considered decisions.
- Willingness to mentor or manage other Business Operations professionals based on business need.
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.
- 12+ years of relevant clinical development experience preferred with a B.A./B.S. degree; or
10+ years of relevant clinical development experience preferred with an advanced degree. - 3+ years of experience directly negotiating full scope CRO agreements at task and resource by region level and/or building CRO resourcing models.
- 2+ years people management experience preferred.
- Ability to utilize complex Microsoft Excel formulas and functions – e.g. VLOOKUP, INDEX, MATCH and pivots.
- Experience with writing macros or other programming languages a plus.
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 $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/.
