Careers

Clinical Trial Manager

Description

Neoleukin Therapeutics is looking for an experienced Clinical Trial Manager to join our Clinical Operations team. This key position will function as the Protocol Lead and execute clinical trials (pre-IND through Phase 1-4) for oncology and autoimmunity contributing to our clinical development program(s). If you are a resourceful, independent, collaborative clinical development expert looking to join a fast-growing organization, please apply!


Responsibilities

  • Clinical Operations oversight of clinical trial(s) as Protocol Lead
  • Drive study deliverables to align with company objectives
  • Lead the evaluation, selection and management of study sites and vendors to ensure successful clinical trial execution
  • Lead study risk assessments and trend reviews
  • Oversee negotiation of site budgets and drive site contract process
  • Interface with CROs and clinical site Investigators and staff to ensure optimal site relationships (15% travel expected)
  • Review clinical study protocols, informed consent forms, CRF completion guidelines and other clinical documents
  • Develop site and patient facing documents and study plans
  • Serve as co-monitor at sites for quality oversight as needed
  • Review monitoring visit reports
  • Plan and participate in site initiation visits, study meetings, and vendor meetings


Qualifications

  • Bachelor’s degree in a scientific or healthcare discipline preferred
  • Minimum of 6 years of experience in clinical drug development in the pharmaceutical/biotech industry required, previous Protocol Lead experience on global clinical trial required
  • Experience in the oversight of all operational aspects of clinical studies required
  • Experience managing clinical trials, CROs and multiple vendors, budgets, and timelines
  • Experience monitoring clinical studies and conducting site visits, including Site Initiation Visits etc.
  • Experience reviewing clinical protocols, ICF, and CSR required
  • Experience in oncology and biologics preferred
  • Experience leading a study team of collaborative clinical professionals
  • Strong leadership skills and self-awareness, with proactive and positive approach to problem solving
  • Excellent oral, written, and medical communication skills required
  • Ability to thrive in a fast-paced and entrepreneurial environment
  • Ability to function at a high level in a team setting whether leading the group or contributing independently
  • Supervisory experience preferred
  • Flexibility to adapt to changing needs in real time
  • Excitement about the vision and mission of Neoleukin Therapeutics


Applications can be submitted to careers@neoleukin.com

Neoleukin Therapeutics is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or age, and Neoleukin will not tolerate discrimination or harassment based on any of the above characteristics.