About the role

  • Act as “second-in-command” to the CEO, actively contributing to building and developing the company
  • Drive the implementation of company systems and processes (e.g. QMS, SharePoint, website) in collaboration with QA
  • Project management for all CMC- and tox-related aspects of pre-clinical and clinical studies.
  • Plan, manage, and ensure delivery of tasks in line with SOPs, timelines, and quality requirements
  • Serve as primary point of contact with sponsors, CROs, vendors, and regulatory authorities
  • Prepare and support regulatory and ethics submissions, including CMC documentation
  • Manage project budgets and contribute to sponsor proposals
  • Lead proactive vendor management for PET-tracer precursor manufacturers and other providers (toxicology CROs, PET centers, storage facilities)
  • Establish agreements, oversee stability studies, and manage supply to ongoing projects
  • Conduct vendor qualification and perform vendor oversight in collaboration with QA
  • Manage associated budgets
  • Identify and monitor potential risks, maintain risk management logs, and develop contingency plans
  • Participate in senior management interactions (e.g. our Board) as required.

Requirements

  • University degree in life sciences, pharmacy, chemistry, or related field.
  • Extensive experience of project management of CMC- and tox-related activities for pre-clinical (animal models and tox) and/or clinical studies
  • Experience with regulatory submissions and interactions in support of clinical trial applications
  • Strong leadership skills and ability to work strategically as well as operationally
  • Extensive experience of operating in and complying with GMP and GLP regulations
  • Have business acumen and experience of contractual negotiations
  • Proven track record of vendor qualification and management
  • Experience in radiochemistry, PET-tracer or radiopharmaceuticals development
  • Experience of operating in other quality controlled environments such as GCP, GDP, and GDocP

Benefits

  • Hybrid work environment
  • Opportunity to make a real impact in drug development

Job title

Chief Operating Officer

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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