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Lead Clinical Operations Manager

2 months ago

Cambridge, Massachusetts, United States Pheon Therapeutics Full time

Position Overview:

Pheon Therapeutics is seeking a dedicated Senior Clinical Trial Manager / Associate Director to work closely with the Head of Clinical Development. This role is essential for ensuring effective operational oversight and support for all clinical trial initiatives, including vendor management and oversight from the initiation phase through to completion.

Key Responsibilities:

  • Take charge of Clinical Operations for one or more of Pheon's clinical stage programs.
  • Contribute to the strategic planning of early phase clinical development.
  • Be responsible for executing clinical development strategies by effectively planning and managing early phase clinical projects.
  • Work autonomously, providing insights and overseeing the creation of clinical plans, study protocols, and essential clinical documents (including synopses, protocols, informed consent forms, investigator brochures, and clinical study reports).
  • Proactively oversee and manage sites, contract research organizations (CROs), and all other vendors associated with the study to ensure that trial deliverables and performance objectives are achieved while maintaining a high standard of operational excellence.
  • Lead site initiation activities, coordinating both Pheon-led and CRO-led start-up processes.
  • Ensure studies are conducted within the agreed timelines and budgetary constraints.
  • Maintain compliance and quality throughout the clinical trial process, ensuring accurate documentation of trial progress.
  • Oversee the establishment, technical integration, and upkeep of clinical systems such as databases, clinical trial management systems (CTMS), electronic trial master files (eTMF), and other platforms for trial execution and data collection.
  • Guarantee that all trials are conducted in accordance with relevant ICH/GCP guidelines and applicable local regulations.

Qualifications:

  • Experience in clinical operations within the biotechnology sector is essential.
  • Experience in oncology and early phase drug development is required.
  • A bachelor's degree in life sciences is preferred.
  • Demonstrated strong leadership and project management capabilities.
  • Proven expertise in clinical trial operations, particularly in site initiation.
  • A minimum of 8 years of clinical operations experience in a pharmaceutical, biotechnology, or CRO environment, including at least 5 years managing CROs and clinical trial vendors.
  • Exceptional leadership skills with the ability to guide and support cross-functional teams.
  • Strong interpersonal, organizational, and multitasking abilities.
  • Thorough understanding of GCP/ICH and EU guidelines for conducting clinical trials, with inspection experience.
  • Willingness to commute as required.

Pheon Therapeutics is committed to providing equal employment opportunities to all qualified applicants without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Please note: No employment agencies will be considered, and the company is not responsible for any fees related to unsolicited candidates.