Associate Medical Director HematologyOncology Remote

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

*Must be legally authorized to work in the United States(or Canada) withoutsponsorship.

*Must be able to pass a comprehensive background check whichincludes a drug screening(where applicable).

Summarized Purpose:
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. labelling reconciliation documents CTD modules REMS RMP and CSR).

General Support:
Ensures tasks delegated to pharmacovigilance 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 PPDs 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. 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. 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. Contributes to departmental process improvement initiatives.

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

Marketed Products Support:
Manages signal detection activities scientifically reviews aggregate reports contributes to label updates supports dossier maintenance and risk management activities. Medically reviews adverse event and serious adverse event data from all sources (solicited spontaneous literature etc) as contracted.

Education and Experience:

• MD required with specialization/formal training in Oncology or Hemato-Oncology (active medical license and board certifications are preferred but not required).
• Candidates should have at least one of the following:
• Clinical experience in treating patients associated with the applicants training (comparable to 2 years)
• 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 medical monitoring (comparable to 2 years).

• For Medical Director Level candidates should have Clinical experience in treating patients associated with the applicants training (comparable to 2 years) AND:
• Suitable clinical trial experience in a Contract Research Organization pharmaceutical companyor as a principal investigator (comparable to 2 years) in the industry; Or
• Direct experience in safety/Pharmacovigilance (comparable to 2 years)
• Preferences are towards individuals with direct 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.

Knowledge Skills and Abilities:

• Therapeutic expertise across one or more medical specialty or sub-specialties (one being Oncology or Hemato-Oncology)
• Excellent interpersonal skills influencing and team building skills
• Understanding of 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 within pharmacovigilance
• Strong well supported decision-making problem solving organizational skills and analytical skills
• Excellent oral and written communication skills
• Working knowledge of relevant safety databases (e.g. MedDRA)
• Flexibility to travel domestically and internationally for short periods
• Ability to work independently analyse work with attention to detail process and prioritize sensitive complex information
• Proficiency in computer productivity applications (e.g. word processor spreadsheets and presentations) required
• Fluent in spoken and written English
• Capable of multitasking and good organization skills

Working Conditions and 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.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast simple repeated movementsof 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 laptopcomputer 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 toand 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 workschedules to meet goals. Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditionswith 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!

Compensation