Descripción de la oferta
The Regional Medical Director (RMD) is an integral member of the metabolic/obesity clinical sciences group, who assists and extends Clinical Sciences across the metabolic portfolio on assigned studies at the regional level .
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brSite engagement and training
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bro Retraining as needed (e.g., Meeting with potential sites, in collaboration with CTL, to discuss the program/assess of their interest
bro Patient recruitment issues (ongoing oversight): Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and trouble shooting
br~ o Helping address site medical/clinical questions as a first line for those questions that are straightforward or previously addressed or to help coordinate a response with the Medical Director for those that are not straightforward/new
br This includes referencing and updating the FAQ, as applicable
br Medical Director should always be copied on the email correspondence for oversight
br~ o Helping site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is needed
br Feedback should also be provided to the study team if the query text could be improved for clarity
brEnsuring that all information has been gathered as expected (i.e., in collaboration with the CRA, if additional support is needed during escalation process
br o In collaboration with the CTL, retrain the site, to prevent future deviations/address any misunderstandings by the site
br~ o Helping to ensure that the site has followed up with patients in the event of lost to follow-up / all appropriate steps have been taken (in collaboration with the CTL) and that any protocol specific requirements have been met
br~ o For instance, in PNH studies, help to ensure that all LDH values that are not done/unable to be performed are rapidly chased to ensure a repeat is done as quickly as possible, in collaboration with the CRA/CTL
bro For other studies, may require help in working with site to obtain any key missing assessments (eg, images, PK samples, biomarker samples), in collaboration with the CRA/CTL
br~ Laboratory reference range
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bro In collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory data
br~ The global medical director can be pulled in if the issue cannot be easily resolved
brWeekly meetings with medical director (if possible) or weekly communication with medical director, at a minimum
brMay provide clinical assistance and feedback on PI interest in proposed studies at the local level
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brMD PhD, or PharmD ; 8+ years of industry clinical development experience
br~ Expertise in clinical trials and clinical development
br~ Strong understanding of the Metabolic/Obesity clinical research landscape and implementation and conduct of these clinical trials
br~ Demonstrated ability to work well in cross functional and geographically diverse teams
br~ Cross cultural awareness and fluent in the local language of primary country assignment in addition to English
br~ Computer skills including Excel, Word, and PowerPoint
br~ A willingness to travel up to 65%, which may include local, regional and international travel
br~ Valid driver’s license
