Associate Medical Director - Oncology - Remote U.S

at  Thermo Fisher Scientific

JOB DESCRIPTION

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. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

EDUCATION AND EXPERIENCE:

• MD required with specialization in Oncology or Hemato-Oncology (active medical license preferred). Clinical experience in treating patients associated with the applicants training (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).
  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. Med Dir and Sr Med Dir requires additional CRO/Pharma industry experience and maybe considered.

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, analyze work with attention to detail, process and prioritize sensitive complex information
• Proficiency in basic computer productivity applications (e.g. word processor, spreadsheets and presentations)
• Fluent in spoken and written English

PHYSICAL REQUIREMENTS:

• 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.

Please refer the Job description for details