Associate Director, Clinical Operations
Harpoon Therapeutics is a clinical-stage immunotherapy company located in South San Francisco.
The company is developing novel biologics that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel T cell engagers 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, pancreatic cancers and mesothelioma. 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-expressing 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 microenvironment. 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.
We are seeking an experienced candidate at the Associate Director level, and this position reports to the VP, Development Operations & Project Management.
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.
- 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
- 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
- 10+ 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