Senior Medical Director Immunology

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Senior Medical Director Immunology, Cork City

Client:

Location: Cork City, Ireland

Job Category:

Other

EU work permit required:

Yes

Job Reference:

34202111bb11

Job Views:

180

Posted:

03.03.2025

Expiry Date:

17.04.2025

Job Description:

Senior Medical Director, Immunology
Our client, a global pharma organisation, is 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 Immunology products. The ideal candidate will have clinical training, therapeutic area expertise, and people management experience. This is a permanent role with hybrid working.

Responsibilities

• Creating a positive work environment to enable high performing teams
• Working with direct reports to set performance objectives and create development plans; evaluate performance and provide coaching
• Serving as a medical expert in late phase drug development and clinical research
• Contributing to the identification, prioritization, and assessment of collaboration opportunities
• Leading the conduct and reporting of global clinical trials to support regulatory interactions, registration, and delivery of innovative treatments
• Reviewing and approving protocols, study reports, data dissemination, and disclosures
• Contributing to strategy development and execution of the product scientific data disclosure plan, including manuscript and congress preparation and review
• Representing the team in Periodic Safety reviews and ad hoc safety topic reports as required
• Planning, responding, and reviewing regulatory requests and interactions, regulatory submissions, label updates, etc.
• Contributing 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
• Interacting and building relationships with external parties including collaborators, investigators, clinicians, and thought leaders
• Ensuring that all activities of the medical team comply with current local and international regulations, laws, guidance (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