Associate Medical Director - Oncology(Remote U.S/Canada)

at  Thermo Fisher Scientific

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

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).