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Regional medical director (rmd), metabolic/obesity (eu)

Madrid
The Medical Affairs Company
Publicada el 11 diciembre
Descripción

Regional Medical Director (RMD), Metabolic/Obesity (EU)

TMAC - Madrid, Spain

Tagged: Clinical Research, Director, TMAC, Field Medical, Oncology, Pharmaceutical

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 oncology portfolio on assigned studies at the regional level.

Duties and Responsibilities:

1. Site engagement and trainingA cadence of touchpoints with sites on a regular basis Meeting with sites and presenting at PSVs, SIVsRetraining as needed (., due to amendments)
2. Recruitment issuesSite identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program/assess of their interestPatient recruitment issues (ongoing oversight): Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and trouble shooting
3. Answering questions from sitesHelping 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/newThis includes referencing and updating the FAQ, as applicableMedical Director should always be copied on the email correspondence for oversight
4. Assisting with eligibility assessmentsHelp perform eligibility checks or address urgent eligibility questions prior to randomization
5. Assisting with query closureHelping the site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is neededFeedback should also be provided to the study team if the query text could be improved for clarityHelping 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 (., the site has taken all reasonable steps to obtain the information, in collaboration with the CRA, if additional support is needed during escalation processEnsure that all questions have been answered/follow-up assessments have been doneThis may include requesting additional assessments for a complete evaluation/specialist consultation, etc.
6. Protocol DeviationsIn collaboration with the CTL, retrain the site, to prevent future deviations/address any misunderstandings by the site
7. Retention issuesHelping 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
8. Missing assessmentsFor 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/CTLFor 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
9. Laboratory reference rangeIn collaboration with the CRA, ensure that the laboratory reference ranges are provided for local laboratory data
10. Site issuesDiscussion 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
11. Attend CSTs, if possible
12. Weekly meetings with medical director (if possible) or weekly communication with medical director, at a minimum
13. May provide clinical assistance and feedback on PI interest in proposed studies at the local level

Qualifications and Experience:

14. MD PhD, or PharmD; MD strongly preferred
15. 8+ years of industry clinical development experience
16. Expertise in clinical trials and clinical development
17. Strong understanding of the Metabolic/Obesity clinical research landscape and implementation and conduct of these clinical trials
18. Demonstrated ability to develop and maintain excellent working relationships with both internal stakeholders and study investigators and site staff
19. Demonstrated ability to work well in cross functional and geographically diverse teams
20. Ability to communicate and work independently with scientific/technical personnel with excellent oral presentation skills
21. Ability to think critically, and demonstrated troubleshooting and problem-solving skills
22. Excellent initiative and judgment, and demonstrated ability to positively represent Regeneron in a compliant manner
23. Cross cultural awareness and fluent in the local language of primary country assignment in addition to English
24. Computer skills including Excel, Word, and PowerPoint
25. A willingness to travel up to 65%, which may include local, regional and international travel
26. Valid driver’s license
Posted: Thursday, December 11, 2025
Job # 3637

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