Medical Director, Clinical Labs

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose:

Leads the growth of laboratory operations by integrating operational processes, business development, research & development and quality assurance functions. Sets operating standards, forecasts and establishes operating budgets. Provides medical consultation, client support and resolution. Principle Investigator over in-house review board studies.

Key responsibilities:

• Provides medical consultation, client support and resolution.
• Principle Investigator over in-house review board studies.
• 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.

Keys to Success

Education and Experience:

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

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

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!