Medical Director, Lab Operations

*Work Schedule
• Standard (Mon-Fri)
• Environmental Conditions
• Office
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• Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit [***](***).
• Division Summary:
• Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
• Title: Medical Director/ Lab Director
• Location: Highland Heights, KY (Relocation provided if needed)
• Position Summary:
• Oversees key aspects of capital and capacity management of North American and EU laboratories and oversee Validation testing. Aligns growth expectations with campus footprints and personnel where necessary. Plans and develops long term campus strategies to coincide with market trends, evaluating current and future geographies. Manages the laboratory capital budgets, develops business cases for investment and expansion, with agility to pivot as environments evolve. Build and maintains strategic relationships with clients and partners with operational business development staff.
• Key Responsibilities:
• Negotiates and executes project contracts, defines project scope, pricing and business and contractual interactions with clients, business development and inside sales. Supports sales/marketing efforts and builds and maintains client relations.
• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
• Financial management of projects, revenues and costs and ensures the financial goals for the business are met, strategic planning and capabilities development.
• Oversees laboratory operations and ensures compliance to company SOP's and policies and client requirements.
• Procures and allocates personnel and analytical instrumentation, IT and space needs to appropriate areas based on business needs.
• Provides medical consultation to team members and answers study related medical questions. Communicates with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. Deviates from current approved study protocol only if it is in the medical emergent safety needs of a subject.
• Leads the monitoring, evaluation and action plan as needed on safety variables (adverse events, laboratory/ECG abnormalities, changes in subject medical status and un-blinding requests) during a clinical trial.
• Assesses reported adverse events and determines causality and study drug relationship. Assesses and determines the clinical significance of out-of-range laboratory values and other observed abnormalities noted within safety assessments.
• Develops and implements departmental process improvement initiatives.
• Trains and supervises more junior team members.
• Drive strategic department initiatives.
• Qualifications:
• MD or equivalent required. Active medical licensure preferred.
5+ years of management responsibility Strong leadership skills
Candidates should have a combination of clinical experience and industry experience as follows:
• Clinical experience in treating patients in the specialty or sub-specialty associated with the applicant's training (comparable to 2 years) and one of the following:
• Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Knowledge, Skills and Abilities:
• Full understanding of GMP, ICH guidelines and other regulatory requirements
• Strong knowledge of the drug development industry
• Strong knowledge of personnel and fiscal management
• Strong knowledge of chromatography, dissolution and other analytical instrumentation operation and troubleshooting
• Proficient with Microsoft Office
• Excellent written and verbal communication skills
• Excellent time management and organization skills
• Strong attention to detail
• Ability to multi-task
• Excellent critical thinking skills to support quality decision making
• Working Conditions and Environment:
• Work is performed in an office and/or laboratory and/or clinic environment with exposure to electrical office equipment.
• Frequently drives to site locations, frequently travels within the United States, occasional international travel.
• Rare exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required in frequently such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions