This commercial stage pharmaceutical organisation focusses on developing and delivering innovative new treatments to help improve the lives of patients with rare or orphan diseases. This organisation is committed to building a diversified portfolio of commercially attractive, best in class, proprietary new drugs to address some of these rare and debilitating illnesses. The organisation's leadership team boasts a wealth of experience in identifying, commercialising and delivering new treatments across global markets and it's this success that is driving the organisation's expansion at the business Corporate Offices here in Dublin and the need for a Clinical Project Lead has arisen to join their growing Development Group.
- Manage and oversee the project objectives and quality of deliverables.
- Ensuring organisational deliverables and milestones are met; good collaboration with the key grant partners.
- Ensure that the qualification and selection of service providers (including manufacturing, CMC, toxicology, external laboratories and clinical research organisation), including the relevant tendering process are of high quality and within the program budget.
- Work with the service providers such that scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
- Develop proactive contingency plans to mitigate potential development program risks; escalates key risks and issues and implement solutions or corrective actions as needed.
- Ensure project is compliant with all pertinent regulations and guidelines.
- Provide preclinical and clinical input into regulatory documents such as drug designation, INDs, NDA/MAAs and preparation for regulatory interactions.
- Manage the clinical project budget (monthly reporting) and early identification of risks.
- Provision of monthly comprehensive project update.
- BSc or MSc (PhD preferred) in life sciences with a minimum of 5 years in preclinical/clinical project management,
- Experience in the pharmaceutical/commercial/CRO development, with particular importance given to preclinical expertise
- Project management experience, including laboratory/CRO/vendor management, monitoring of budget scope, preclinical/clinical site monitoring, and knowledge of basic data management / biostatistics processes and pharmacovigilance.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.