Associate Medical Director/Medical Director - Neurology - Remote U.S

at  Thermo Fisher Scientific

JOB DESCRIPTION

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, part of Thermo Fisher Scientific — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

QUALIFICATIONS, EDUCATION AND EXPERIENCE:

• MD or equivalent required. Active medical licensure preferred.
• Candidates should have at least one of the following:
• Clinical experience in treating patients in the speciality or sub-speciality associated with the applicants training (comparable to 2 years). i.e: Neurologist
• Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry.
• Direct experience in safety/Pharmacovigilance (comparable to 2 years).
• Candidates with industry experience(CRO/Pharma) maybe considered for Medical Director/Senior Medical Director level.
  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
• 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 within PV

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).

ESSENTIAL FUNCTIONS:

Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.