Dir Med Operations

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 – To enable 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.

Alongside clinical research through our PPD® clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.

We are currently looking to recruit a Dir Med Operations in Poland.

Discover Impactful Work:

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 standard methodology and overall contribution to the achievement of company targets. Accountable for building exceptional relations with country medical council and other key opinion leaders.

A day in the Life:

• 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 standard methodology 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.) specifically Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company (“PPD”), collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD. including conducting patient appointments in the most efficient and effective manner to improve 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 partners.
• 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.
  
  

Qualifications:

Education and Experience:

• Valid medical degree within the country with at least 10 years working as a licensed Physician as well as other medical licences as may be required within country(i.e., dispensing) and at least 8 years’ experience working in clinical research with PI responsibility
• Valid registration as a medical practitioner, with a medical license in good standing, with unrestricted ability to practice in place of work
• Valid ICH GCP certificate
• At least 5+ years management responsibility, if leading a team
  
  

Knowledge, Skills and Abilities:

• Strong critical thinking, decision making, analytical and problem solving skills
• Exceptional communication skills and ability to work with a cross-functional team to get results
• Demonstrated ability to influence and collaborate at all levels throughout the organization
• Excellent written, verbal and presentation skills
• Ability to effectively prioritize and manage multiple projects
• Strong planning, organizational and project management skills
• Ability to manage outside agencies in order to fulfil project objectives
• Self-starter with ability to thrive under pressure in a fast paced environment
• Skilled in Word, Excel, and PowerPoint and proficient with the Internet
• Solid understanding of the clinical regulations as well as practical knowledge of common local, medical practices and treatment habits
• Advanced understanding of clinical medicine/clinical pharmacology, and associated disciplines and drug development principles would be an advantage but is not an essential requirement
• Demonstrated ability to maintain scientific credibility while being commercially supportive, and to communicate scientific results and effectively respond to data queries from customers and/or consultants would be an advantage but is not essential
• Excellent interpersonal and verbal/written English language communication skills
• Demonstrated ability to translate data and metrics into predictable business insight
• Ability to perform effectively under pressure and to practice strong organizational skills when faced with multiple, time-sensitive priorities
• Ability to work with minimal guidance and proactively seek guidance on complex tasks
• Ability to multitask and operate within a deadline driven environment
• Open-minded and dedicated team player who thrives in a dynamic and international environment
• Continuous development, with attention to high quality, high ambitions and results