Job Description

　　Remote U.S Based. This role has oversite of the east cost territory of clinical trial sites, applicants who are in located in this area are highly preferred.

　　Travel: 25-40% annually.

　　Summarized Purpose:

　　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.) specifically 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.

　　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(can be acquired after starting)

　　At least 5+ years management responsibility, if leading a team

　　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:

　　Strong critical thinking, decision making, analytical and problem solving skills

　　Exceptional communication skills and ability to work with a cross-functional team to drive 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

　　Management Role:

　　Director role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of director skills and responsibilities as demonstrated by consistent, multi-year successful performance. Directs through subordinate management. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.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.