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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Medical Director Immunology


Reference:SCAWJV-204422 Location: Cork
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Medical Director

Senior Medical Director, Immunology
Our client, a global pharma organisation are currently recruiting for a Senior Medical Director to join a new team within the organisation. As Senior Medical Director you will be responsible for leading and representing the global development team for a portfolio of late-lifecycle of Immunology products. As well as having clinical training and therapeutic area expertise, the ideal candidate will have people management experience. This is a permanent role with hybrid working.


Responsibilities

  • Creating a positive work environment to enable high performing teams
  • Work with direct reports to set performance objectives and create development plans; evaluate performance and provide coaching
  • Serve as a medical expert in late phase drug development and clinical research
  • Contribute to the identification, prioritization, and assessment of collaboration opportunities
  • Lead the conduct and reporting of global clinical trials to support regulatory interactions, registration, and delivery of innovative treatments
  • Review and approve protocols, study reports, data dissemination and disclosures
  • Contribute to strategy development and execution of the product scientific data disclosure plan, including manuscript and congress preparation and review
  • Represent the team in Periodic Safety reviews and ad hocsafety topic reports as required
  • Plan, respond, and review regulatory requests and interactions, regulatory submissions, label updates, etc
  • Contribute to the preparation, review, and approval of the product Investigator Brochures (IB), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Profile, and any other right-to-operate documents as required
  • Interact and build relationships with external parties including collaborators, investigators, clinicians, and thought leaders
  • Ensure that all activities of the medical team comply with current local and international regulations, laws, guidance’s (for example, FDA, ICH, CHMP etc.), Good Clinical Practices (GCPs), company standards, policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research
Requirements
  • Medical doctor
  • Physicians must have completed education and training at a medical school that meets the requirements of the US Liaison Committee on Medical Education (LCME)
  • US trained physicians (Medical Doctor or Doctor of Osteopathy) must have achieved board eligibility or certification in Immunology, Internal medicine, Rheumatology or Dermatology
  • A minimum of 10 years work experience in specialties related to Immunology or Internal medicine
  • Minimum of 3 years of professional experience in pharmaceutical drug development with demonstrated experience and knowledge of clinical research and the drug development process
  • Previous people management experience
  • Strong administrative and leadership skills
  • Fluent in English, written and verbal communications
  • Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team
For more information contact Sinéad Cullen on +353879500821 or [email protected]