Director Medical Operations

Job Description

Summarised Purpose for the Director Medical Operations:

Provides medical oversight, overall leadership, accountability and responsibility for the efficiency, quality and performance of medical conduct within a country/region. Takes responsibility for the management of physicians as well as patient safety within the territory. Ensures best practice and overall contribution to the achievement of company targets. Accountable for building exceptional relations with country medical council and other key opinion leaders.Essential Functions:

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical 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. Promotes all aspects of Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards.
• Supports study implementation and involved in the planning of study delivery at sites to ensure maximum patient enrolment and delivery.
• Drives medical operational delivery by embedding and creating a culture of delivery excellence.
• Actively involved in feasibility, new trends and studies and recommend best approach at a country level.
• Involved in the planning of studies to ensure maximum patient enrolment and delivery.
• Cascades global strategic business plan and direction to country/territory.
• Leads the medical teams to develop strategies and tactics to support planned growth and to increase efficiency and effectiveness.
• Attends and participates in the weekly delivery calls and give guidance to support the achievement of delivery goals.
• Manages and controls costs within agreed budgets where applicable.
• Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents and safety issues. Adheres to COP’s/SOP’s and study specific guidelines.
• Drives compliance with company and sponsor quality objectives ensuring effective and efficient best practice processes, procedures and documentation to aid delivery and meet customer requirements.
• Provides or arrange training to all research physicians within the territory (study specific, operational standards, acute performance issues, etc.) including conducting patient appointments in the most efficient and effective
• manner to maximize results.
• Provides guidance to research physicians regarding the clinical management of patients.
• Monitors all safety variables (AE, Lab abnormalities, changes in medical status, un-blinding request) and discusses all medical concerns with relevant
• stakeholders.
• Provides sound and poised review of the likely risks and benefits of a study to management.
• Provides medical review of adverse events of special interest, serious adverse
• events and clinical outcomes events reported by study sites.
• Ensures team focuses on the need and urgency to deliver randomizations.
• Develops plans with team to fix leading and lagging metrics.

Policy & StrategyEstablishes policies appropriate for the function. Interprets and recommendsmodifications to company-wide policies and practices. Develops and is responsiblefor budgets, schedules, and performance standards.Freedom to Act Objectives are defined in collaboration with senior management and results assessedfrom a relatively long-term perspective.Liaison Interacts with senior management, and others concerning matters of significance tothe company. Conducts business and technical briefings for senior and top

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.