Position Summary:
The Manager, Research & Development leads, manages and coordinates all R&D activity, reporting to the Scientific lead or VP clinical trial laboratory operations. Responsible for liaising with the Principal Scientist and laboratory operations to coordinate scientific strategy laboratory requirements, validations, SOPs, trouble shooting and training, as required. Ensures all documentation is appropriate for the regulatory environment. Oversees and directs all R&D client interaction and external (third party) laboratory interaction for the R&D team coordinating the development of 3PL and client strategies and meetings. Ensures R&D processes are effective and oversees the pre-award and post- award support.
Key Responsibilities:
Maintain daily departmental performance by managing resources, prioritizing tasks, and developing and monitoring metrics.
Facilitate communication as a point of escalation or strategic point of contact for the department.
Identify, lead, and/or participate in cross functional process improvement initiatives to optimize operational capabilities.
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
Works with Principal Scientists and VP lab ops to support R&D and operations for strategic initiatives including new biomarkers and technologies.
Creates plan for conference attendance and external marketing.
Manage client programs and strategic initiatives in collaboration with the laboratory and other cross-functional departments.
Assigns R&D team and supports team with Clients and 3PLs for oversight of haematology and chemistry and pharmacodynamic (PD) analysis.
Coordinate and lead R&D team through the coordination of marketing material related to scientific strategy across all service lines and strategic initiatives
Accountable for design and execution of all clinical trials method validations in collaboration with operational teams and Principal Scientists
Ensures all methods and validations are done according to all applicable regulatory guidelines, including but not limited to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP) NYSH / UK EMEA.
Responsible for ensuring teams are trained and compliant with all regulations as appropriate.
Manage and coordinate change control activities relating to technologies.
Liaise with QA to complete internal and external audit findings.
Coordinate trouble-shooting activities with laboratory operations and Principal Scientists
Coordinate and responsible for execution of scientific support of internal and external partners based on challenges and new technologies)
Oversee the harmonisation of global SOPs process as appropriate
Works with Principal Scientists and oversees 3PL relationships for R&D team.
Coordinates the development of 3PL and Client strategy and attends meetings as appropriate.
Ensures process of supporting pre award is effective and works with the Principal Scientists to suggest new testing requirements in line with client requests and the scientific strategy.
Coordinates the translation of the analytical strategy into operational plans.
Plans the initiation and oversees the execution of validations as appropriate.
Oversees method onboarding activities in a suitable timeframe to support clinical trials activities as appropriate with support of Principal Scientists.
Perform other duties as needed.
Preferred Qualifications:
PhD in life sciences
Experience in Microsoft Office
EP Evaluator experience
Experience leading
Understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), NYSH and UKEMEA.
Application of science in a regulatory environment including validation of methodologies for clinical trials.
Experience leading teams, projects, and troubleshooting strongly preferred.
Minimum Qualifications:
BS in Life Sciences
7 years in Laboratory experience including 2 years of supervisory or leadership experience
Required Licensure/Certifications:
None
EDUCATION:
LICENSES / CERTIFICATIONS:
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.For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.
Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.
PAY RANGE:
$80,000.00 - $120,000.00CITY:
POSTAL CODE:
The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.