Employment Type: Full-Time
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. 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 Harpoon plans to initiate a Phase 1/2 trial in the second half of 2020. 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.
* Reports to Executive Director, Clinical Development
* Works in close coordination with the medical director(s) and clinical operations on assigned clinical programs and individual studies. May serve as the clinical representative/lead on individual studies as needed
* Serves as author and contributor to key clinical documents such as protocols, amendments, CSRs, IBs and DSURs, etc.
* Partners with Project Leadership and Clinical Operations in driving the timelines
* Responsible for clinical sections of Informed Consent Forms for individual studies
* In close collaboration with Data Management and Clinical Operations, responsible for the clinical sections of eCRFs, CRF Completion Guidelines and the internal Data Integrity Review Plan
* Works with Project Teams in responding to HA inquiries and collaborates with Clinical Operations in responding to Ethics Committee/IRB inquiries
* Performs ongoing data review from a clinical perspective
* Responsible for the preparation for and presentation of data for CRCs
* Clinical delegate and representative to the Study Execution Teams
* Maintains scientific and clinical knowledge in the relevant disease and therapeutic area(s). Conducts a review of published literature or of clinical and preclinical reports in the field to provide the context for clinical development programs
* Collaborates with external stakeholders, such as clinical investigators, scientists and KOLs, as well as cross functional internal teams such as research, business development, legal, commercial etc.
* Presents at key meetings, both internally and externally, to convey the clinical development perspective
* Authors and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and any other distributed materials and coordinates reviews by concerned stakeholders. Coordinates submissions to scientific meetings and/or other appropriate venues
* Contributes to and/or leads any other projects, when assigned or otherwise requested
Skills and Qualifications
* Pharm D, PhD, MD or other health allied experience (nurse, physician assistant, public health)
* Experience in oncology and/or demonstrated ability to work across therapeutic areas preferred
* 3-5 years industry clinical trial experience or equivalent
* Experience working on a cross functional clinical team (or equivalent)
* Experience authoring global clinical development plan and clinical study protocol.
* Experience with HA and IRB/EC, IND and NDA/BLA filing.
* Experience across drug development phases
* Knowledge of Good Clinical Practices, FDA and ICH regulations is required
* Excellent influential and negotiating skills to challenge, motivate and gain alignment from others
* Excellent cross-functional team leadership and participation skills
* Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
* Excellent interpersonal skills to be able to build strong internal and external relationships
* Excellent written and verbal communication skills as well as the ability to present information to a wide range of groups/entities
* Excellent attention to detail
* Ability to work with minimal supervision and goal oriented
* Data review experience