Senior/Principal Scientist, Clinical Pharmacology
Harpoon Therapeutics is an early-stage biotech company located in South San Francisco. The Company is developing biologics with novel molecular formats to engage and activate immune cells for the treatment of cancer and other diseases. With multiple programs positioned to enter clinical development in the next two years, we are evolving into a clinical stage company. We are seeking a highly motivated clinical pharmacologist to assume critical functions in our drug development clinical programs. The successful candidate will be a leader in building a new functional area of clinical pharmacology and the required infrastructures for Harpoon Therapeutics.
- Lead the company’s clinical pharmacology efforts; act as the subject matter expert and a key stakeholder in product development teams (PDTs).
- Interact with discovery research, nonclinical and clinical science to identify relevant secondary endpoints and to design and execute safety and pharmacodynamic biomarker monitoring plans for the company’s clinical trials.
- Apply state-of-the-art quantitative pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation approaches to guide determination of safe and effective dose regimens based on evolving data to advance clinical trials.
- Manage CRO’s and vendors to implement methods and analyze patient samples; develop data transfer plans, organize and interpret data, and present analysis to key stakeholders (PDTs, research, management, and board of directors).
- Present findings in the forms of meeting abstracts, posters, and/or manuscripts in scientific journals.
- Author documents for regulatory submissions.
- A PhD with 5+, a MS or BS with 8+ years of experience in clinical pharmacology modeling and simulation in the biotech/pharmaceutical industry.
- Demonstrated experience and track record 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.
- Knowledge in the biological significance and clinical relevance of common clinical pathology and hematology endpoints to the pharmacological effects of experimental drugs for cancer treatment.
- 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.
- Ability to explain the principles of modeling, experimental observations and meaning of the data to a wider lay audience.
- Knowledge in regulatory guidance, requirements and expectations in the US and internationally.