BRIS.101 – Clinical Project Manager

UNITY Biotechnology is a nascent integrated biopharmaceutical company discovering and developing medicines to treat chronic diseases associated with aging. We are located in the San Francisco Bay Area and are seeking to hire a Clinical Project Manager (CPM). The CPM will be responsible for providing clinical project support for a given Clinical Program within UNITY’s Senolytic Drug Development Program. In addition, the successful candidate will collaborate with the Head of Clinical Operations and Chief Medical Officer to facilitate attainment of the translational research goals of the Clinical Development Plan. The position provides vital support for clinical systems infrastructure and clinical administrative and organizational needs. In addition, the CPM will ensure that clinical implementation methodology is conducted in accordance with Good Clinical Practice, applicable rules and regulations, ethical standards, and UNITY’s Standard Operating Procedures and guidelines. The CPM will provide programmatic support that may include but not be limited to the following activity:

  • Developing clinical plans, timelines and budgets
  • Managing all operational aspects of trial implementation, including ensuring compliance with GCP, SOPs, and Regulatory requirements
  • Developing Clinical Protocols and associated documentation, such as Informed Consent Forms (ICFs), eCRFs, Data Capture Tools (Patient Reported Outcomes), and technical study manuals
  • Managing regulatory and core clinical documentation (Trial Master File)
  • Overseeing Quality Management as it pertains to a given trial or program
  • Managing clinical strategic outsourcing, including vendor selection and oversight, and development of the vendor management plan
  • Managing Central Laboratories and working with the Translational Research team to support the Biomarker Plan.

Requirements:

  • Bachelor’s degree (BS/BA/BScN or higher) in a scientific field
  • 5+ years of clinical study management experience in the biopharmaceutical domain and at least three years of clinical study lead or project management experience. Total 8-10 years of relevant experience preferred.
  • At least two years of experience managing outsourced studies. Direct site monitoring and experience of managing audits or undertaking inspection preparedness preferred
  • Sound computer skills: proficient in Excel, Word, and EDC systems, and able to learn new systems and train others. Highly competent in an electronic environment (prior experience with eTMF systems highly advantageous)
  • Strong understanding of clinical trial domain and documentation management.
  • Understanding of GCLP and the conduct of clinical trial assays is advantageous
  • Strong understanding of laboratory matters as they pertain to clinical trials, and an ability to track and aggregate information from disparate systems (laboratory portals, EDC systems, Vendor tracking tools)
  • Ability to work with a high degree of initiative and independence while exercising appropriate judgement
  • Thorough knowledge  of  ICH/GCP guidelines, FDA requirements  for  INDs, NDAs, and drug approval process
  • An understanding of Quality Management and the Quality Cycle as it pertains to the clinical trial domain. A strong understanding of the lifecycle of Clinical Quality
  • Documentation (SOPs) and ability to manage in a document control environment
  • Meticulous attention to detail and ability to collaborate in development of clinical plans and execute to those plans in a timely manner
  • Very strong organizational, communication (oral and written), and interpersonal skills
  • Advanced problem-solving skills and ability to think creatively and apply innovative solutions to achieve the desired outcome
  • Multi-tasking skills and ability to manage multiple competing tasks, tracking multiple deadlines and competing activitiesPlease send resume and cover letter to careers@unitybiotechnology.com