Medical Director, Clinical Research
|Job Title:||Medical Director, Clinical Research|
|Contact Name:||Reece Mitellas|
|Job Published:||October 03, 2018 01:55|
The (M.D.) Clinical Research Medical Director, in US Clinical Development & Medical Affairs, will provide a high level of medical expertise in the area of Clinical Drug Development in the Immunology & Dermatology area.
Primary medical responsibility for Development Clinical Trials - this includes protocol feasibility, physician to physician contact, protocol training, medical issue/question management, safety review and local regulatory interaction. May be called upon to provide strategic medical input for a given therapeutic area into protocol design at a global level. Identify/involve investigators and key opinion leaders in order to exploit the value of the as signed project(s) in the contest of the investigational product(s). Discussion with key opinion leaders regarding compounds in early development.
- Provide medical expertise specific to US.
- Lead and/or perform protocol, country and site feasibility.
- Provide consolidated feasibility and site selection input to global and US teams.
- Provide protocol, Risk management plan & disease training as appropriate at Investigator's Meetings or scientific venues or internally.
- Perform local AE review and provide general medical support for safety issues:
- Provide medical expertise support to pharmacovigilance activities.
- Be aware of clinical trial SAEs on a country level.
- Follow-up with the Investigator for additional information or clarifications as needed.
- When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc.
- Review and try to resolve local medical issues / questions that arise during the entire course of the study
- Assist in writing country or site specific Informed Consent Forms (ICF).
- Provide strategic medical input into protocol design at a global level.
- Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical input as appropriate as this relates to clinical trials.
- Support CRA/ and Global teams in interaction with regional regulatory agencies.
- Provide assistance to CRAs and site for IEC/IRB Interactions.
- Support planning, implementation and follow-up of regulatory agency inspections and internal audits.
- M.D. Required