Scientist/Senior Scientist, Clinical Pharmacology
Harpoon Therapeutics is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for small cell lung cancer and other DLL3-associated tumors. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
With multiple programs in clinical trials, we are recruiting a highly motivated scientist to join the Clinical Pharmacology team to support the advancement of the Harpoon’s clinical pipeline. This scientist will assist in developing Clinical Pharmacology and Translational Medicine strategies and will play an integral role in the Company’s success. Area of expertise for this individual include hands-on non-compartmental analyses, population pharmacokinetic/pharmacodynamic (PK/PD) modeling, and simulations, using pharmacokinetic, model-based, and drug therapeutic principles and the knowledge of drug development processes and regulatory guidances.
- Contribute to the Company’s clinical pharmacology efforts; act as the subject matter expert and a key stakeholder in research and clinical teams.
- Organize and interpret pharmacokinetic and pharmacodynamic data.
- Conduct hands-on non-clinical and clinical data analysis including non-compartmental analyses, population PK/PD modeling and exposure response (efficacy and safety) analyses based on evolving data to advance clinical trials.
- Interact with clinical operations, clinical science, data management and biostatics to design clinical studies.
- Work closely with biosample management for the proper collection, processing, and testing of pharmacokinetic and biomarker samples.
- Present findings to key stakeholders (PDTs, research, management, and board of directors) and in the forms of meeting abstracts, posters, and/or manuscripts in scientific journals.
- Author documents for regulatory submissions and contribute to the clinical study protocols and reports.
- A PharmD or PhD with 2+, a MS or BS with 4+ years of experience in clinical pharmacology and modeling and simulation in the biotech/pharmaceutical industry. Equivalent experience may be accepted. Post-doctoral work may serve as experience.
- Demonstrated experience in designing and implementing PK/PD modeling strategies and plan in support of clinical development of experimental drugs; expertise in biologics for the treatment of cancer is preferred.
- Proficiency in PK and PK/PD data analysis, interpretation, and reporting.
- Must have hands-on experience with data analysis, non-compartmental and PK/PD modeling and using data processing software such as Phoenix WinNonlin, R, NONMEM, and/or MONOLIX. Good working knowledge of graphing software such as SigmaPlot, Prism, JMP, or R is required.
- Ability to work in a dynamic, fast-paced, timeline-based environment and across organization, have excellent communication skills, and demonstrate sound judgment and problem-solving capabilities.
- Ability to explain the principles of modeling, experimental observations and meaning of the data to a wider lay audience.
- Working knowledge in the human immune system and the functions of lymphocyte subsets in relation to the clinical development of immune-oncology drugs is a major plus.
- Knowledge in regulatory guidance, requirements and expectations in the US and internationally, and ICH and GCP is a plus.