Regional Medical Director; RMD), Metabolics​/Obesity; EU

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

The Medical Affairs Company (TMAC)

Territory: All EU countries as required.

• 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 interest
  • Patient recruitment issues (ongoing oversight):
    Meeting with sites, in collaboration with CTL, to identify hurdles and troubleshooting
• Answering questions from sites
  • Address site medical/clinical questions as the first line for straightforward or previously addressed issues, or coordinate a response with the Medical Director for complex cases
  • Reference and update FAQ as applicable
  • Ensure the Medical Director is copied on email correspondence for oversight
• Assisting with eligibility assessments
  • Perform eligibility checks or address urgent eligibility questions prior to randomization
• Assisting with query closure
  • Help sites understand requirements to close a medical query
  • Provide feedback on query wording for clarity
  • Ensure safety event information is sufficient, gathering all required data in collaboration with the CRA, and that all follow‑up assessments are completed
  • Request additional assessments for a complete evaluation or specialist consultation if needed
• Protocol deviations
  • Collaborate with CTL to retrain the site, prevent future deviations, and address misunderstandings
• Retention issues
  • Ensure the site follows up with lost‑to‑follow‑up patients and meets all protocol‑specific requirements, in collaboration with CTL
• Missing assessments
  • In PNH studies, chase missing LDH values promptly, in collaboration with CRA/CTL
  • For other studies, facilitate retrieval of key missing assessments (e.g., images, PK samples, biomarker samples), in collaboration with CRA/CTL
• Laboratory reference range
  • Collaborate with CRA to provide local laboratory reference ranges for data
• Site issues
  • Discuss potential quality issues with sites (first‑line physician dialogue)
  • Escalate to global Medical Director if unresolved
• Attend CSTs if possible
• Weekly meetings or communication with the medical director, at minimum
• Provide clinical assistance and feedback on PI interest in proposed studies at the local level

• MD, PhD, or Pharm
  
  D; 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 of these trials
• Demonstrated ability to develop and maintain excellent working relationships with internal stakeholders, investigators, and site staff
• Demonstrated ability to work well in cross‑functional and geographically diverse teams
• Excellent oral presentation skills and ability to communicate independently with scientific/technical personnel
• Strong critical thinking, troubleshooting, and problem‑solving skills
• Excellent initiative and judgment, able to positively represent the company in a compliant manner
• Cross‑cultural awareness and fluency in the local language of the primary country assignment in addition to English
• Computer skills:
  Excel, Word, and Power Point
• Willingness to travel up to 65%, including local, regional, and international travel
• Valid driver’s license

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Research and Science

Industries: Pharmaceutical Manufacturing, Research Services, and Biotechnology Research