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Medical Director

hace 1 mes

Madrid, Madrid, España IQVIA A tiempo completo
Job Overview

The Medical Director plays a crucial role in providing medical and scientific support to clinical research programs, study teams, and investigators. This position requires a strong understanding of medical and scientific principles, as well as excellent communication and leadership skills.

Key Responsibilities
  • Provide medical and scientific input to clinical research programs, including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting
  • Ensure medical activities run according to GCP and operate with highest efficiency
  • Establish and maintain a network of medical/scientific consultants, etc.
  • Supervise and manage Medical Director activities
  • Interact with clients regarding drug development programs, study design and protocol
  • Review and provide input for protocol development. Interact with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interact in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables.
  • Provide project team training on protocol and/or therapeutic areas
  • Assist team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.
  • Participate in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations
  • Presents protocol and/or safety reporting information at investigator meetings
  • Develops project medical monitoring plans as requested
  • Provides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.
  • Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study
  • Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed
  • Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data
  • In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)
  • Interact with appropriate FDA officials concerning safety and other study related issues, as requested
  • Provides medical review of eCRFs for clinical accuracy
  • Provides medical review of data analysis plan
  • Reviews safety fields at case freeze for reconciliation (if needed)
  • Works with data group to reconcile SAE events as needed
  • Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends
  • Reviews data tables, listings, and figures
  • Reviews and/or writes portions of final clinical study report
  • May assist sponsor in choosing committee members
  • May serve as a non-voting member to convene and organize proceedings
  • May develop operating guidelines in conjunction with committee members and submits these to sponsor for review
  • May determine data flow with sponsor to ensure reporting accuracy
  • Can ensure DSMB feedback is given to sites for IRBs
  • Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development
  • Supports business development activities with proposal development and sales presentations
  • Participates in feasibility discussions relating to specific project proposals
  • Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
  • Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities
  • Participate in a variety of team quality improvement efforts as necessary
  • Perform other related duties as assigned or requested by the Chief Medical Officer
Qualifications

Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education

10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development

3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience

Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus

Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment

Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities

Excellent oral and written communications skills as well as interpersonal skills are essential

Oncology; Hematology;

Current or prior license to practice medicine; board certification/eligibility ideal (Preference)

Board Certified / Board Eligible: Oncology/ Hematology (Required)

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at