Sr. Director, Scientific Affairs

Responsibilities

• Partner with VP Clinical operations to identify and operationalize scientific strategy
• Responsible for the performance of the scientific teams by managing resources, prioritizing tasks, and developing and monitoring metrics
• Promote and uphold a high performing culture through effective talent planning, selection, onboarding, and continuing education
• Curate and deliver comprehensive training plans and materials to foster successful onboarding and employee performance
• Provide ongoing coaching and mentorship supported by routine performance metrics to identify clear performance feedback and career development plans
• Foster professional development through continuous coaching and performance management
• Oversee Principal Scientists and works with key operational and regulatory leadership for strategic initiatives including new biomarkers and technologies
• Oversee and manage the R&D team to assign resource in line with required validations and laboratory support of safety testing
• Collaborates with VP, Clinical Operations to create plans for conference attendance and external marketing
• Serve as the point of escalation to provide scientific solutions as required for internal teams and external clients
• Identify, lead, and/or participate in cross functional process improvement initiatives to optimize capabilities
• Coordinates the development of 3PL and Client strategy and attends meetings as appropriate
• Assign Principal Scientist team to support non-safety testing aspects to expand service offerings and provide scientific expertise for 3PL assignment and regulatory audits
• Assign R&D team to support safety testing to expand service offering and provide expertise for client and 3PL safety enquiries
• Oversee and help resolve internal and external audit findings

Requirements

• PhD + 10 years in Clinical Trials regulatory laboratory or BS in Life Sciences + 15 years in Clinical Trials regulatory laboratory experience
• 5 years of progressive leadership experience

Preferred Qualifications

• NYS Certification of Qualification through New York State Department of Health, Wadsworth Center in: Clinical Chemistry, Diagnostic Immunology, Endocrinology, and/or Hematology
• Understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), NYSH and UK EMEA
• Experience leading teams, projects, and troubleshooting essential
• Board Certification in one of the following areas is preferred: ABB – American Board of Bioanalysis, ABCC – American Board of Clinical Chemistry, ABFT – American Board of Forensic Toxicology (limited to individuals with a doctoral degree), ABHI – American Board of Histocompatibility and Immunogenetics, ABMGG – American Board of Medical Genetics and Genomics (formerly known as American Board of Medical Genetics (ABMG)), ABMLI – American Board of Medical Laboratory Immunology, ABMM – American Board of Medical Microbiology, NRCC – National Registry of Certified Chemists (limited to individuals with a doctoral degree)