This is a rare opportunity to join one of the most exciting young global biopharmaceutical companies, headquartered here in Dublin. With a rich development and commercial pipeline our client is focused on rare and orphan diseases.
Reporting to the Head of Clinical Development, the Director Global Clinical Research Physician will be an experienced physician with the responsibility for design, implementation, and data analysis of the clinical development program of selected Biopharmaceutical products.
The successful candidate will be responsible for clinical strategy, design, and execution; data review and interpretation, key role in strategy & content of all related regulatory documents – on a number of programs.
Key Scope of this role:
- Provide medical leadership and work effectively within cross functional teams.
- Provide medical/clinical expertise to the development team and the wider company organisation.
- Engage as a peer with external experts and investigators in an ethical manner, increasing the standing of the company.
- Support for Head of Clinical Development; act up as and when required.
Develop, review and contribute to study protocols, eCRF design, medical monitor plan and completion guidelines, laboratory manuals, informed consent forms, project plans and other study-related documents.
Responsible for medical monitoring on specific clinical trials, to a high standard and in compliance with all relevant guidelines and regulations.
Provide clinical expert knowledge in the therapeutic area under development.
Provide clinical input into various clinical trial regulatory and ethics committee documents.
Participation in Independent Data Management Committee.
Work closely with the pharmacovigilance and quality teams to ensure that patient safety is comprehensively evaluated.
Establish a strong network of external experts to enable high calibre innovative research.
Requirements for Director, Global Clinical Research Physician:
Medical Degree (MD).
10 year's Clinical Medicine experience, 5 years’ experience of which in similar role in pharmaceutical development (Pharmaceuticals or CRO).
Broad therapeutic areas expertise is preferred.
Demonstrates deep medical knowledge and the ability to evaluate and analyse complex scientific and clinical data.
Experience working in or developing cross functional teams to set up, and conduct clinical studies, preferable in the US and the EU.
Broad knowledge of clinical research and differing healthcare systems, regulatory and reimbursement requirements across major regions.
Experienced in engaging with national and international regulatory agencies and reimbursement agencies.
Familiarity with financial budgeting or reporting.
Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
Travel of up to 25% may be required depending on project needs.
Please phone Larry on +353 (0)1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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