(Senior) Medical Director Dermatology

(Senior) Medical Director Dermatology

Synteract

Anywhere in Europe

Position Overview

The (Senior) Medical Director provides leadership to the global medical function including medical monitoring. This position collaborates with Medical Affairs Leadership on the ongoing development of the Medical Department and contributes to the business plan at both the tactical and strategic level. Directly and through subordinate staff, ensures the successful management of medical advisory and medical monitoring projects in compliance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and the Company's Standard Operating Procedures (SOPs). Additionally, this position involves cross-functional communications, strategic planning, and participation in clients' strategic decision-making, physician review, medical monitoring and critical interactions with scientific advisors.

Specific tasks would include

  • Participates in Business Development activity including proposal development/budgeting, feasibility input, and sales presentations;
  • Contributes to protocol and product development strategic planning, providing consultancy advice in related areas internally and to sponsors as required;
  • Assists with the assignment, transitioning, and assimilation of individuals to work as Medical Advisor and Medical Monitor on projects;
  • Assures that Medical Advisors and Medical Monitors are adequately trained. Participates in development and provides training for Medical Advisors and Monitors. Ensures procedural training is complete, documented, and in compliance;
  • Interacts with other departments to ensure required quality of service is provided to a sponsor;
  • Serves as a Medical Advisor and Medical Monitor, sometimes providing 24/7 or after hours coverage per client project requirements;
  • Provides project physician support to clinical study teams during the execution of clinical research studies, including protocol development, eCRF development, therapeutic area training, protocol queries, patient eligibility determination, clinical/safety data review, and clinical summary report generation;
  • Serves as liaison with external clients, IRBs, DMCs, vendors, and regulatory agencies for study-related medical issues;
  • Trains the study team on medical aspects of planned clinical trials;
  • May participate in study start-up, Investigator, client meetings, FDA meetings and meetings with further national authorities, audits/inspections;
  • Reviews and contributes to medical aspects of trial-related documents such as Medical Monitoring Plan, Study Protocol, and Investigator Brochure;
  • Reviews medical aspects of protocol eligibility/compliance, waivers, deviations, dose escalation determinations, CRFs, clinical study reports, and regulatory submissions;
  • Reviews laboratory results and results of other examinations of study subjects;
  • Collects, monitors and analyzes information related to adverse events (AEs) and serious adverse events (SAEs). Reviews associated safety case narratives to assure claims of causality and expectedness are reasonable and medically sound;
  • Reviews or assists in the review of medial coding to assure congruency with the terms reported in the case report form (CRF) and provides re-coding of event if appropriate;
  • Participates in masked or unmasked data review and Data Safety Monitoring Board activities;
  • Assists in the procurement and management of contractor, advisory, and full-time Medical staff;
  • Responsible for assigning respective Medical Advisor and Medical Monitor teams, coordinating Medical Monitoring support, and overseeing medical issues on all assigned therapeutic area projects;
  • Supervisory responsibilities include but are not limited to providing technical and operational guidance and direction, performance management, ensuring deliverables are met, administering company policies, SOPs, employee development, timekeeping and labor law compliance;
  • Assists in the development and implementation of department Standard Operating Procedures (SOPs) and Work Instructions (WIs), Ensures adherence to department guidelines, applicable ethical, regulatory and department standards.

Qualifications

  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O) or equivalent required in the field of Dermatology;
  • 5+ years experience working as a Medical Advisor/Medical Monitor in clinical studies, preferably with prior CRO experience. Board certification and active medical license is preferred;
  • In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety and drug development process and regulations;
  • Excellent proficiency in Microsoft Word, Excel, and PowerPoint, etc.;
  • Effective verbal and writing skills; English + local language, if relevant;
  • Flexibility to travel.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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