Regional Medical Director (Rmd), Metabolics/Obesity (Eu)
3 days ago
Córdoba
ppTerritory includes but not limited to: All of EU countries as needed. /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 level. /ph3Responsibilities /h3ulliSite engagement and trainingolliA cadence of touchpoints with sites on a regular basis. /liliMeeting with sites and presenting at PSVs, SIVs. /liliRetraining as needed (e.g., due to amendments). /li /ol /liliRecruitment issuesolliSite identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program/assess of their interest. /liliPatient recruitment issues (ongoing oversight): Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and troubleshooting. /li /ol /liliAnswering questions from sitesolliHelping address site medical/clinical questions as a first line for those that are straightforward or previously addressed or to help coordinate a response with the Medical Director for those that are not straightforward/new. /liliReferencing and updating the FAQ, as applicable; Medical Director should always be copied on the email correspondence for oversight. /li /ol /liliAssisting with eligibility assessmentsolliHelp perform eligibility checks or address urgent eligibility questions prior to randomization. /li /ol /liliAssisting with query closureolliHelping site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is needed. Feedback should also be provided to the study team if the query text could be improved for clarity. /liliEnsuring that the information that we must have to describe a safety event is sufficient, including all information gathered as expected (i.e., the site has taken all reasonable steps to obtain the information, etc.) in collaboration with the CRA. /liliIf additional support is needed during escalation process, ensure that all questions have been answered/follow‑up assessments have been done. This may include requesting additional assessments for a complete evaluation/specialist consultation, etc. /li /ol /liliProtocol DeviationsolliIn collaboration with the CTL, retrain the site to prevent future deviations/address any misunderstandings by the site. /li /ol /liliRetention issuesolliHelping 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. /li /ol /liliMissing assessmentsolliFor 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. /liliFor 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. /li /ol /liliLaboratory reference rangeolliIn collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory data. /li /ol /liliSite issuesolliDiscussion with the sites for any potential quality issues /concerns requiring physician to physician discussion (first line). The global medical director can be pulled in if the issue cannot be easily resolved. /li /ol /liliAttend 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 /ulh3Qualifications and Experience /h3ulliMD PhD, or PharmD; MD strongly preferred. /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 /p #J-18808-Ljbffr