Associate Director, Clinical Operations

Harpoon Therapeutics is a clinical-stage immuno-oncology company focused on the discovery and development of novel, proprietary bispecific T cell engaging biologic drug candidates for the treatment of various cancers. Harpoon’s first product, HPN424, is in clinical development for prostate cancer, and the second product HPN536 is in clinical testing for mesothelin over-expressing tumors, such as lung, pancreatic and ovarian cancers. Harpoon currently has two additional products in development and intends to introduce these into clinical development by the end of 2020. Harpoon is led by an experienced management team and has raised more than $200 million from leading life science investors. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and clinical research.

We are seeking an experienced candidate at the Associate Director level as part of the critical functions in transitioning Harpoon Therapeutics to a clinical stage company. This position reports to the Sr. Director, 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
• 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