Director, Scientific Affairs
The Director, Scientific Affairs leads strategy, implementation and advancement of ACM Global Laboratories’ clinical trials testing by managing but internal and external scientific partners. Leads a team of Scientists, Analysts and Specialists that advise the organization on new testing methods, understand and recommend internal/external solutions and drive development and execution of new testing methods to meet clients’ needs. The Director, Scientific Affairs reports to the Vice President of Clinical Operations and partners closely with Business Development, Proposals Management, Study Management and Laboratory Operations.
STATUS: Full Time
LOCATION: ACM Global Laboratories (Rochester, NY; relocation available)
- Ph.D. in chemical, physical, or biological science.
- Minimum of 5 years of experience in scientific affairs, clinical trials, or clinical laboratory.
- Strategy. Lead strategy development, implementation and ongoing advancement of new testing and procedures offered to ensure ACM Global Laboratories meets the needs of all clients, today and in the future. Partner closely with the Vice President of Clinical Operations and the Principal Scientists to advise the organization on new service offerings, methodology, and instrumentation.
- Partnerships. Develop, select and manage reference laboratory partnerships to ensure that ACM Global Laboratories’ capabilities, both internal and external, are well positioned to support client needs. Manage all aspects of our reference laboratory partnerships, including but not limited to: cost & pricing, volume & utilization, quality metrics, method development and validation. Ensure proper review of proposals and the evaluation of appropriate testing and/or methodology is offered by ACM Global Laboratories. Work closely with internal experts and leverage reference lab partnerships to meet client needs.
- Leadership. Develop and monitory Key Performance Indicators that support business needs; including but not limited to reference lab utilization, quality issues, RFP turnaround and more. Manage a team of specialized Principal Scientists that ensure the technical methodology, develop protocols and oversee laboratory instrument selection, evaluation, validation and implementation. Manage a team that support the anatomic pathology; ensure resources and capacity needs are met, regulatory and quality requirements are maintained. Oversee the activities of the analytical team that supports Scientific Affairs; ensure they are the bridge between our Principal Scientists & Anatomic Pathology teams and the Request For Proposals process.
- Quality & Continuous Improvement. Responsible for meeting quality requirements for all internal/external testing; identify and resolve quality issues in a timely manner. Actively partner with Quality Assurance. Implement continuous improvement efforts to drive cost savings, efficiency, and quality assurance.