Description

HOW WE CARE FOR YOU:
At ACM Global Laboratories, we are dedicated to getting health care right. Our robust benefits and total rewards foster employee wellbeing, professional development and personal growth. We care for your career while improving patients lives.

• Pension Plan
• Retirement Plan
• Comprehensive Benefits Package
• Tuition Reimbursement
• Benefits Effective Date of Hire
• Employee Referral Program
• Employee Assistance Program
• Employee Discounts
• Paid Time Off & Holidays
• Bonus Eligible

SUMMARY

The Director, Scientific Affairs leads strategy, implementation and advancement of ACM Global Laboratories' clinical trials testing by collaborating with internal partners and identifying and managing external scientific referral lab partners. Leads a team of, Analysts and Specialists that advise the organization by understanding and recommending internal/external solutions and works collaboratively with R&D on the 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.

ACM Global Laboratories is a growing international organization that provides continued opportunities for internal advancement. At ACM you will be part of a team that is focused on improving people's lives where you are supported by leadership and colleagues. We are backed by a large healthcare network in the complex and rewarding field of advanced laboratory science. Your voice is heard, and with that, you have an ability to make an impact on the organization and influence your professional growth.

STATUS: Full Time

LOCATION: Remote

DEPARTMENT: Scientific Affairs

SCHEDULE: Days

ATTRIBUTES

• Experience in vendor management preferred.
• Experience in a highly regulated environment; Experience with College of American Pathology (CAP), Clinical Laboratory Improvement Amendments (CLIA), Medicines & Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) preferred.
• Experience leading a global remote staff.

MINIMUM QUALIFICATIONS

• Bachelor's Degree required; Ph.D. in Chemical, Physical, or Biological science highly preferred.
• Minimum of 5 years of experience in scientific affairs, clinical trials, or clinical laboratory.

RESPONSIBILITIES

• Vendor Management. 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. Work closely with internal experts and leverage reference lab partnerships to meet client needs. Oversee and ensure the addition of any reference lab testing into our LIS/LIMs systems.
  
• Scientific Liaison. Ensure proper review of proposals and the evaluation of appropriate testing and/or methodology is offered by ACM Global Laboratories. Develop and monitory Key Performance Indicators that support business needs; including but not limited to reference lab utilization, quality issues, RFP turnaround and more. Partner closely with the Vice President of Clinical Operations and the Principal Scientists to advise the organization on new service offerings, methodology, and instrumentation. Work closely with a team of specialized Principal Scientists that participate in the technical methodology assessments, developing of protocols and laboratory instrument selection, evaluation, validation, and implementation.
  
• Leadership. Manage a team that support the anatomic pathology; ensure resources and capacity needs are met, regulatory and quality requirements are maintained. Manage the Scientific Affairs Team; ensure they are the bridge between our Principal Scientists & Anatomic Pathology teams, the laboratories and the Clinical Trails Proposals team. Provide ongoing coaching, mentorship, career development and performance management to staff. Responsible ensuring the appropriate resources to meet business objectives; ensures hiring, training, and onboarding of staff. Responsible for meeting quality requirements for all internal/external testing; identify and resolve quality issues in a timely manner. Actively partner with Quality Assurance to qualify and retain qualification of our referral lab partners. Implement continuous improvement efforts to drive cost savings, efficiency, and quality assurance.
  

EDUCATION:

• PhD (Required)

PHYSICAL REQUIREMENTS: S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

PAY RANGE: $150,000.00 - $200,000.00

The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran

Minimum Salary: 150000.00 Maximum Salary: 200000.00 Salary Unit: Yearly