Regional Medical Director (Rmd), Metabolics/Obesity (Eu)
hace 2 días
Valladolid
Territory includes but not limited to: All of EU countries as needed. Desplácese hacia abajo para encontrar los detalles completos de la oferta de trabajo, incluyendo la experiencia requerida y las funciones y tareas asociadas. 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. Responsibilities • Site engagement and training, • A cadence of touchpoints with sites on a regular basis., • Meeting with sites and presenting at PSVs, SIVs., • Retraining as needed (e.g., due to amendments)., • Recruitment issues, • Site identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program/assess of their interest., • Patient recruitment issues (ongoing oversight): Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and troubleshooting., • Answering questions from sites, • Helping 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., • Referencing and updating the FAQ, as applicable; Medical Director should always be copied on the email correspondence for oversight., • Assisting with eligibility assessments, • Help perform eligibility checks or address urgent eligibility questions prior to randomization., • Assisting with query closure, • Helping 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., • Ensuring 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., • If 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., • Protocol Deviations, • In collaboration with the CTL, retrain the site to prevent future deviations/address any misunderstandings by the site., • Retention issues, • 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., • Missing assessments, • 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., • 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., • Laboratory reference range, • In collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory data., • Site issues, • Discussion 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., • Attend CSTs, if possible., • Weekly meetings with medical director (if possible) or weekly communication with medical director, at a minimum., • May provide clinical assistance and feedback on PI interest in proposed studies at the local level.Qualifications and Experience, • MD PhD, or PharmD; MD strongly preferred., • 8+ years of industry clinical development experience., • Expertise in clinical trials and clinical development., • Strong understanding of the Metabolic/Obesity clinical research landscape and implementation and conduct of these clinical trials., • Demonstrated ability to develop and maintain excellent working relationships with both internal stakeholders and study investigators and site staff., • Demonstrated ability to work well in cross functional and geographically diverse teams., • Ability to communicate and work independently with scientific/technical personnel with excellent oral presentation skills., • Ability to think critically, and demonstrated troubleshooting and problem‑solving skills., • Excellent initiative and judgment, and demonstrated ability to positively represent Regeneron in a compliant manner., • Cross cultural awareness and fluent in the local language of primary country assignment in addition to English., • Computer skills including Excel, Word, and PowerPoint., • A willingness to travel up to 65%, which may include local, regional and international travel. xcskxlj, • Valid driver’s license. #J-18808-Ljbffr