Careers

Clinical Program Manager

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. 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 is in a Phase 1/2 trial for small cell lung cancer and other DLL3-associated tumors. 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. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.

We are seeking an experienced candidate as a Clinical Program Manager, as part of the critical functions in transitioning Harpoon Therapeutics to a clinical stage company. This position reports to the Associate Director of Clinical Operations.

Responsible for providing operational oversight and trial management expertise, leadership, and guidance to Harpoon and third-party study team members for all clinical trials within the Harpoon portfolio.

Responsibilities

  • Work with departmental leadership to establish strategic plans and objectives
  • Help establish departmental methods, techniques, and standards for projects, programs, and people
  • Assist in the preparation and writing of investigator brochures, clinical study reports, clinical sections of regulatory filings, annual reports, etc.
  • Collaborate with Quality staff to develop a quality plan for clinical trials
  • Identify, hire, and oversee appropriate CROs and other third-party vendors
  • Develop action plans to address issues with investigators, clinical sites, or Clinical Research Associates and direct study monitoring priorities
  • Negotiate and manage budget, invoices, and payments
  • Develop trial-related training materials for Harpoon team members, clinical site staff, and third parties
  • Track, report, and review study quality metrics and identifies activities warranted to meet trial goals and timelines
  • Review clinical data listings and summary tables; oversee the generation and resolution of queries
  • Write, prepare, and/or contribute to clinical protocols and amendments, ICFs, CRFs, study manuals and other clinical documents
  • Ensure execution of trials according to the study protocol and procedures, SOPs, GCP and regulations
  • Perform other duties as requested

Qualifications

  • Bachelor’s degree in a scientific or health care discipline preferred and/or training or equivalent combination of education and experience.  Advanced degree(s) in scientific research, medicine, nursing, law, or business is preferred
  • 8+ years’ experience in oncology, first-in-human, and/or orphan drug development strongly preferred
  • At least 10 years of trial management experience in a pharmaceutical/biotech setting; experience overseeing global clinical studies strongly preferred
  • Demonstrated successful management of CROs
  • Demonstrated success at clinical trial initiation through completion, including excellent project management skills
  • Demonstrated ability to motivate clinical site personnel to maintain and/or accelerate timelines in order to achieve clinical operational milestones  
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Excellent understanding and demonstrated application of Good Clinical Practices (GCP) and ICH Guidelines.  Able to comply with safety standards and respect privacy and confidentiality
  • Superb verbal and written communication skills
  • Excellent organizational skills along with strong attention to detail
  • Ability to work both independently and collaboratively with cross-functional teams
  • Ability to utilize critical thinking to analyze problems which may require multiple factors and approaches