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Associate Director, Clinical Pharmacology and Modeling and Simulation

South San Francisco, CA

Description

Harpoon Therapeutics is a clinical-stage immunotherapy company located in South San Francisco. 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. 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. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. 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. The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.

Overview

With multiple programs in clinical trials, Harpoon is recruiting a highly motivated individual with a strong background in clinical pharmacology, pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulations, quantitative systems pharmacology (QSP), drug development and regulatory requirements to join the Clinical Pharmacology team.

This Associate Director of Clinical Pharmacology and Modeling and Simulation, reporting into the Sr. Director of Clinical Pharmacology, will be responsible for Clinical Pharmacology and Pharmacometrics activities for the company’s current and upcoming investigational biological product(s). Key responsibilities for this position include developing and implementing Clinical Pharmacology and Pharmacometrics plans, applying model-based strategies, and representing Clinical Pharmacology on research and clinical teams. This candidate will work in close partnership with Translational Medicine, Medical Monitors, Clinical Science, Data Management, Biostatistics, and Research with the goal of supporting key decisions and advancing Harpoon’s pre-clinical and clinical pipeline.

RESPONSIBILITIES

  • Act as Clinical Pharmacology subject matter expert and a key stakeholder in research and clinical teams.
  • Design and execute mechanistic PK/PD modeling to enable translation of preclinical data as well as inform clinical dose selection decisions.
  • Evaluate and initiate strategies to develop and apply systems pharmacology models to further the understanding of a investigational biological product’s pharmacological activity, efficacy and safety.
  • Explore novel modeling methods and approaches (i.e., quantitative methodologies, pharmacometrics tools, software, hardware, etc).
  • Conduct hands-on non-clinical and clinical data analysis including non-compartmental analyses, population PK/PD modeling and exposure response (efficacy and safety) analyses.
  • Interact with clinical team to design clinical studies and advance investigational biological product(s) through development.
  • Present findings to key stakeholders (product development teams, 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.

QUALIFICATIONS

  • A PharmD or PhD with 6+, a MS or BS with 10 + 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, clinical and pre-clinical development of immune-oncology drugs and T cell engagers is a major plus.
  • Knowledge in regulatory guidance, requirements and expectations in the US and internationally, and ICH and GCP is a plus.