医学总监/高级医学总监 - 呼吸系统

Job Title: Medical Director/Sr Medical Director - Pulmonary
Job Location: Chapel Hill, North Carolina, United States of America
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
Environmental Conditions: Office
Work Schedule: Standard (Mon-Fri)
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join us as a Medical Director/Sr Medical Director – Make an Impact at the Forefront of Innovation

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.

The Medical Director provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
*Must be legally authorized to work in the United States or Canada without sponsorship.
*Must be able to pass a comprehensive background check, which includes a drug screening(where applicable).
What You'll Do:
Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
General Support:

• Ensures tasks delegated to medical monitors are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs.

• Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.

• Provides therapeutic training and protocol training on assigned studies, as requested.

• Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.

Clinical Trial Support:

• Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.

• Discusses all medical concerns with principal investigators and clients (e.g.discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.

• Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.

• Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

Keys to Success:
Education and Experience:
· MD or equivalent required. Active medical licensure preferred but not required. Candidates should have clinical experience in Pulmonary/Critical Care and formal training (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years).

For Senior Medical Director Level:

• MD or equivalent required. Active medical licensure preferred but not required. Candidates should have a combination of clinical experience and industry experience as follows:

• Candidates should have clinical experience in Pulmonary/Critical Care and formal training (i.e residency and/or fellowship), along with patient treatment experience (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; Or

• Direct experience in safety/Pharmacovigilance (comparable to 2 years)

• Preference towards individuals with clinical development/medical monitoring experience

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.
Job leveling at Medical Director or Senior Medical Director will be determined during the consideration process, inclusive of education, experience, therapeutic area(s), and interview results.
Knowledge, Skills and Abilities:

• Therapeutic expertise in Neurology

• Strong decision-making, problem solving, organizational skills and analytical skills

• Excellent oral and written communication skills

• Working knowledge of relevant safety databases (e.g. Medra)

• Flexibility to travel domestically and internationally

• Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information

• Proficiency in basic computer applications

• Fluent in spoken and written English

• Excellent interpersonal, influencing and team building skills

• Understanding guidelines (FDA, ICH, EMA and GCP)

• Working knowledge of biostatistics, data management, and clinical operations procedures

• Ability to act as a mentor/trainer to other staff

Physical Requirements / Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment

• Occasional drives to site locations with occasional travel both domestic and international

• Frequently stationary for 6-8 hours per day

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists

• Frequent mobility required

• Occasional crouching, stooping, bending and twisting of upper body and neck

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences

• Frequently interacts with others to obtain or relate information to diverse groups

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task

• Regular and consistent attendance

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!

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Originally posted on Himalayas