Associate Chief Operating Officer guiding strategic projects and operational tasks at Creditreform. Collaborating with management to ensure effective implementation of prioritised decisions and actions.
About the role
- Chief Operating Officer overseeing operational leadership and vendor management in drug development for Antaros Tracer. Drive strategic growth while ensuring compliance in clinical studies.
Responsibilities
- 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
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Chief Operations Officer driving scale and structure across operations for cosmos GmbH. Collaborating with CEO and teams to establish partnerships and manage performance tracking.
Chief Operations Engineer ensuring 24/7 mission support for Missile Warning Integration and Test at Leidos. Leading a high - performing team and driving operational excellence in a critical role.
COO Office Coordinator in Swiss Re's Chief Operating Office drives strategic initiatives and fosters collaboration while ensuring governance and operational excellence.
AVP, COO for Medical Affairs at CVS Health overseeing medical affairs functions and operations for Aetna. Driving enterprise - level clinical operations and aligning business strategies.
Chief Operating Officer at BBSRC overseeing operations, strategy alignment, and organisational transformation efforts. Leading a team to support high - quality, resilient outcomes across various functions.
Executive Assistant supporting COO and CCO at WRITER, a rapidly growing generative AI company. Manage complex schedules, logistics, and communications for executives in a hybrid model.
Chief Operations Officer leading operations, finance, and procurement for an R&D - focused high - tech startup. Collaborating with various teams to ensure efficient scaling and execution of strategic priorities.
Chief Operating Officer leading the Compliance - as - a - Service operations for S+P Compliance. Overseeing client relationships, regulatory monitoring, and implementation of innovative compliance solutions.
Chief Operating Officer overseeing daily operations and strategic vision for I.M. Systems Group. Leading growth objectives and high - level operational activities in a federal government support firm.