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Senior Medical Director Oncology and Diabetes
1 month ago
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Senior Medical Director Oncology and Diabetes, CorkClient: [Client Name]
Location: Cork, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: a547dd3ea550
Job Views: 81
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:Senior Medical Director Oncology and Diabetes
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 Oncology and Diabetes 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.
- 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 hoc safety 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 (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 Oncology, Hematology, Diabetes, or Internal medicine.
- 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.
- Strong administrative and leadership skills.
- Fluent in English, both written and verbal communications.
- Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.