COO at S+P Compliance Services overseeing compliance operations and strategic client relationships. Leading innovative compliance solutions for financial institutions and FinTechs in a hybrid environment.
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
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