Senior Director, Clinical Pharmacology
South San Francisco, CA
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.
With multiple programs in clinical trials, reporting into the SVP, Translational Medicine, we are recruiting a highly motivated professional to head the critical function of Clinical Pharmacology and to oversee PK analysis and pharmacometrics activities. The successful candidate will be the leader in building the department of Clinical Pharmacology In order to support the advancement of the Company’s clinical-stage pipeline.
- Lead the Company’s Clinical Pharmacology and sample operations group and team members.
- 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.
- Apply state-of-the-art quantitative pharmacokinetic and systems pharmacology (QSP) methods in modeling and simulation based on nonclinical data and evolving clinical data.
- 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.
Skills and Qualifications
- A PhD with 12+ years of experience of experience in clinical pharmacology and modeling and simulation in the biotech/pharmaceutical industry.
- Demonstrated experience, proficiency, and track record in running and/or overseeing clinical pharmacology programs in clinical trials.
- In depth knowledge 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.
- Demonstrated ability to motivate and manage staff with a successful track record of developing high-performing staff.
- 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.
- Ability to work in a dynamic, fast-paced, timeline-based environment