Associate Director, Clinical Operations

South San Francisco, CA 94080

Posted: 10/21/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16624

Job Description


 

Associate Director, Clinical Operations

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

 

 

 

 

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Jesse Ashworth

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