Regional Medical Director (RMD), Metabolics/Obesity (EU) - The Medical Affairs Company (TMAC)
hace 2 días
Badajoz
Territory includes but not limited to: All of EU countries as needed 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. Duties and Responsibilities: • Site engagement and training o A cadence of touchpoints with sites on a regular basis o Meeting with sites and presenting at PSVs, SIVs o Retraining as needed (e.g., due to amendments) • Recruitment issues o Site identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program/assess of their interest o 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 • Answering questions from sites 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 This includes referencing and updating the FAQ, as applicable Medical Director should always be copied on the email correspondence for oversight • Assisting with eligibility assessments o Help perform eligibility checks or address urgent eligibility questions prior to randomization • Assisting with query closure o 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 o Helping ensure that the information that we must have to describe a safety event is sufficient, including: 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 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 o In collaboration with the CTL, retrain the site, to prevent future deviations/address any misunderstandings by the site • Retention issues 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 • Missing assessments 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 o 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 o In collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory data • Site issues o 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, • Valid driver’s license
s/n Avenida de Elvas, 06006, Badajoz
