- Work directly with translational sciences subject matter experts on the discovery, validation, and application of novel biomarker strategies in clinical trials
- Manage external vendor selection, contract negotiation and day-to-day progress of external vendor-driven translational sciences team projects
- Serve as biomarker subject matter expert in clinical study meetings to communicate research team strategies and updates
- Work closely and collaboratively with the Clinical Operations team to ensure successful application of biomarker/pharmacodynamic assays in clinical trials (e.g. provide assistance with clinical document writing/review, sample logistics, data transfers, data interpretation, etc.)
- BA/BS or M.S degree in Biological Sciences, Pharmaceutical Sciences or related field
- Minimum of 5 years' experience working in a clinical development/translational research environment (biotech/pharma/CRO)
- Prior experience managing external vendors and working with multidisciplinary project teams
- Broad practical experience with or knowledge of common cell biology and biochemistry laboratory procedures (e.g. flow cytometry, ELISA, qPCR, IHC etc.)
- Project management skills a plus
- Exceptional attention to detail and strong organizational skills to maintain accuracy of sample inventories/databases essential
- Excellent time management skills to simultaneously deliver on multiple time-sensitive objectives
- Effective written and verbal communication skills
- Ability to thrive in a culture of respect, accountability, transparency, and collaboration
- South San Francisco, California
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Biomarker Specialist - South San Francisco, United States - Pliant Therapeutics
Description
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 trial of bexotegrast for the treatment of IPF and INTEGRIS-PSC, a Phase 2a trial of bexotegrast for the treatment of PSC.
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 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
Immediate opening is available for a Biomarker Specialist. This individual will join a dynamic and growing multidisciplinary team focused on advancement of new drug candidates in fibrosis, oncology, and muscular dystrophy.
The successful candidate will work closely with the translational sciences and clinical operations teams to ensure the successful integration of novel biomarker assays into clinical trials in pulmonary fibrosis, biliary fibrosis, oncology, and muscular dystrophy. A strong scientific background and previous experience managing external vendors is preferred.
Responsibilities
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.
Position Location
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 $120,000 - $130,000. 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