Director, Clinical Pharmacology and Modeling and Simulation
Harpoon Therapeutics (ticker: HARP) 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 cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. 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.
Reporting to the Senior Vice President, Translational Medicine, we are seeking a highly motivated professional with a strong background in clinical pharmacology, pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulations, quantitative systems pharmacology (QSP) Translational team. This individual 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 development teams. This candidate will work in close partnership with Medical Monitors, Clinical Science, Data Management, Biostatistics etc. Research with the goal of supporting key decisions and advancing Harpoon’s pre-clinical and clinical pipeline.
- Act as the subject matter expert and a key stakeholder on product development teams (PDTs); collaborate across functional groups to advance the Company’s late stage research and clinical programs and provide adequate support for drug development programs.
- Apply state-of-the-art quantitative pharmacokinetic and systems pharmacology (QSP) methods in modeling and simulation based on nonclinical data and evolving clinical data.
- 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.
- Present findings to key stakeholders at various forums (internal teams, senior leader team, and board of directors) and in the forms of meeting abstracts, posters, and/or manuscripts in scientific journals.
- Develop strategies and direct efforts in clinical pharmacology to meet regulatory requirements as development molecules move through advancing phases of clinical trials.
- Manage CRO’s, consultants, and vendors to implement and validate bioanalytical methods, manage sample analysis, develop data transfer plans, organize, analyze, and interpret data, and present analysis to key stakeholders (PDTs, senior management, and board of directors).
- Present findings in the forms of scientific meeting abstracts, posters, and manuscripts.
- Author documents for regulatory submissions and contribute to the clinical study protocols and reports.
Skills and Qualifications
- A PharmD or PhD with 8+ years of experience in clinical pharmacology and modeling and simulation in the biotech/pharmaceutical industry. (Title to commensurate to experience)
- Demonstrated experience, proficiency, and track record in running and/or overseeing clinical pharmacology programs in clinical trials.
- In depth knowledge and hands-on experience in contemporary PK, population PK, QSP modeling concepts, data analysis, and interpretation; demonstrated record in applying these concepts to support clinical development programs.
- Excellent communication skills, ability to work across organization, especially the ability to explain principles of modeling and biologic meaning of modeling/simulation to lay audience.
- Ability to explain the principles of modeling, experimental observations and meaning of the data to a wider lay audience.
- Well-informed in regulatory guidance, requirements, and expectations in the US and internationally.
- Knowledgeable in the significance and relevance of common clinical pathology and hematology endpoints to the pharmacological effects of cancer therapeutic agents.
- Previous experience in biologics and working knowledge in the human immune system, clinical and pre-clinical development of immune-oncology drugs and T cell engagers are major pluses.
- Knowledge in regulatory guidance, requirements and expectations in the US and internationally, and ICH and GCP is a plus.
- Ability to work in a dynamic, fast-paced, timeline-based environment.
Harpoon anticipates that the annual base salary for this position could range from between $210,000.00 - $240,000.00 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Harpoon is a multistate employer and the salary offered will be market competitive. At Harpoon, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.