Regional Medical Director (RMD), Metabolics/Obesity (EU)
hace 2 días
Castro Urdiales
pTerritory includes but not limited to: All of EU countries as needed /ppbr/ppThe 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 levelb. /b /ppbr/ppbDuties and Responsibilitie /bs: /pulliSite engagement and training /li /ulpo A cadence of touchpoints with sites on a regular basis /ppo Meeting with sites and presenting at PSVs, SIVs /ppo Retraining as needed (e.g., due to amendments) /pulliRecruitment issues /li /ulpo Site identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program/assess of their interest /ppo 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 /pulliAnswering questions from sites /li /ulpo 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 /pp This includes referencing and updating the FAQ, as applicable /pp Medical Director should always be copied on the email correspondence for oversight /pulliAssisting with eligibility assessments /li /ulpo Help perform eligibility checks or address urgent eligibility questions prior to randomization /pulliAssisting with query closure /li /ulpo Helping site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is needed /pp Feedback should also be provided to the study team if the query text could be improved for clarity /ppo Helping ensure that the information that we must have to describe a safety event is sufficient, including: /pp Ensuring that all information has been gathered as expected (i.e., the site has taken all reasonable steps to obtain the information, etc.) in collaboration with the CRA, if additional support is needed during escalation process /pp Ensure that all questions have been answered/follow-up assessments have been done /pp This may include requesting additional assessments for a complete evaluation/specialist consultation, etc. /pulliProtocol Deviations /li /ulpo In collaboration with the CTL, retrain the site, to prevent future deviations/address any misunderstandings by the site /pulliRetention issues /li /ulpo 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 /pulliMissing assessments /li /ulpo 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 /ppo 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 /pulliLaboratory reference range /li /ulpo In collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory data /pulliSite issues /li /ulpo Discussion with the sites for any potential quality issues /concerns requiring physician to physician discussion (first line) /pp The global medical director can be pulled in if the issue cannot be easily resolved /pulliAttend CSTs, if possible /liliWeekly meetings with medical director (if possible) or weekly communication with medical director, at a minimum /liliMay provide clinical assistance and feedback on PI interest in proposed studies at the local level /li /ulpbr/ppbQualifications and Experienc /be: /pulliMD PhD, or PharmDb; MD strongly preferred /b /lili8+ years of industry clinical development experience /liliExpertise in clinical trials and clinical development /liliStrong understanding of the Metabolic/Obesity clinical research landscape and implementation and conduct of these clinical trials /liliDemonstrated ability to develop and maintain excellent working relationships with both internal stakeholders and study investigators and site staff /liliDemonstrated ability to work well in cross functional and geographically diverse teams /liliAbility to communicate and work independently with scientific/technical personnel with excellent oral presentation skills /liliAbility to think critically, and demonstrated troubleshooting and problem-solving skills /liliExcellent initiative and judgment, and demonstrated ability to positively represent Regeneron in a compliant manner /liliCross cultural awareness and fluent in the local language of primary country assignment in addition to English /liliComputer skills including Excel, Word, and PowerPoint /liliA willingness to travel up to 65%, which may include local, regional and international travel /liliValid driver’s license /li /ul
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