Regional Medical Director
hace 20 horas
Vitoria-Gasteiz
ppTerritory includes but not limited to: All of EU countries as needed. /p h3Duties and Responsibilities /h3 ul liSite engagement and training ul liA cadence of touchpoints with sites on a regular basis. /li liMeeting with sites and presenting at PSVs, SIVs. /li liRetraining as needed (e.g., due to amendments). /li /ul /li liRecruitment issues ul liSite identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program and assess interest. /li liPatient recruitment issues (ongoing oversight): Meeting with sites, in collaboration with CTL, to help understand hurdles and troubleshoot recruitment challenges. /li /ul /li liAnswering questions from sites ul liHelp address site medical/clinical questions as a first line for straightforward or previously addressed queries. /li liCoordinate responses with the Medical Director for more complex or new questions, referencing and updating FAQ as applicable. /li liEnsure the Medical Director is copied on email correspondence for oversight. /li /ul /li liAssisting with eligibility assessments ul liHelp perform eligibility checks or address urgent eligibility questions prior to randomization. /li /ul /li liAssisting with query closure ul liHelp sites understand requirements to close medical queries, clarify misunderstandings, and provide feedback to improve query clarity. /li liEnsure sufficient information is provided to describe safety events and that all necessary data is gathered. /li liCollaborate with CRAs to request additional assessments for complete evaluation or specialist consultation when required. /li /ul /li liProtocol Deviations ul liCollaborate with CTL to retrain sites, preventing future deviations and addressing misunderstandings. /li /ul /li liRetention issues ul liEnsure sites follow up with patients lost to follow‑up, taking all appropriate steps and meeting protocol requirements. /li /ul /li liMissing assessments ul liIn PNH studies, chase missing LDH values rapidly to obtain repeats. /li liFor other studies, assist sites in obtaining key missing assessments (e.g., images, PK samples, biomarker samples). /li /ul /li liLaboratory reference range ul liCollaborate with CRAs to provide laboratory reference ranges for local laboratory data. /li /ul /li liSite issues ul liDiscuss potential quality issues or concerns with sites; conduct physician-to-physician discussions as first line. /li liEscalate to global Medical Director if resolution is not straightforward. /li /ul /li liMandated meeting obligations ul liAttend CSTs when possible. /li liWeekly meetings or mandatory communication with the Medical Director. /li liProvide clinical assistance and feedback on PI interest in proposed studies at the local level. /li /ul /li /ul h3Qualifications and Experience /h3 ul liMD, PhD, or PharmD; MD strongly preferred. /li li8+ years of industry clinical development experience. /li liExpertise in clinical trials and clinical development. /li liStrong understanding of the Metabolic/Obesity clinical research landscape and implementation of these trials. /li liDemonstrated ability to develop and maintain excellent working relationships with internal stakeholders, study investigators, and site staff. /li liAbility to work well in cross‑functional and geographically diverse teams. /li liExcellent oral presentation, self‑mandated scientific and technical communication, critical thinking, troubleshooting, and problem‑solving skills. /li liSelf‑initiative, judgment, and positive representation of the company in a compliant manner. /li liCross‑cultural awareness and fluency in the local language of the primary mandatory country assignment, plus English. /li liComputer skills including Excel, Word, and PowerPoint. /li liWillingness to travel up to 65%, which may include local, regional, and international travel. /li liValid driver’s license. /li /ul pRegional Medical Director • Gasteiz, Kingdom Of Spain, ES /p /p #J-18808-Ljbffr
