Senior Director, Scientific Affairs

Job Title: Sr. Director, Scientific Affairs

Department: Research & Development

Location: Rochester, NY | Relocation Package Available

Hours Per Week: 40

Schedule: Days, Monday – Friday

SUMMARY

This role provides strategic scientific leadership to advance ACM’s long-term vision, translating organizational strategy into high-impact scientific execution across global teams of scientists, PhDs, and R&D professionals. Serving as the internal and external scientific ambassador for ACM, the role partners closely with senior leadership, clients, and industry stakeholders to identify gaps, develop innovative scientific solutions, and strengthen service offerings. With global responsibility for scientific leadership, this position drives continuous improvement, ensures scientific rigor and quality, and aligns evolving capabilities with the demands of clinical trials and emerging therapeutic areas. 

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. 
• Perform other duties as needed.

REQUIRED QUALIFICATIONS

• 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  
• Application of science in a regulatory environment including validation of methodologies for clinical trials.  
• 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