Director Clinical Operations, Global role
|Contact Name:||Larry O’Leary|
Our client is a young exciting multinational biopharmaceutical company enjoying exceptional growth combined with a strong high potential pipeline. Rapid expansion has led to the need to create a senior management position in Global Clinical Operations to be based in their Dublin office.
The successful candidate will direct and oversee Global Clinical Operations activities (including oversight of clinical research suppliers CROs, central labs, imaging suppliers, etc.) and study implementation across multiple programs in line with ICH, GCP and company SOPs.
Candidates must have previous experience in oversight of large scale multi-million financial management at the portfolio and functional levels. Also candidates must open to travel.
Scope of this role:
Effectively collaborates, strategizes and partners with cross functional departments including, regulatory, pharmacovigilance, legal, quality, commercial, clinical pharmacology, medical and clinical supply chain to ensure program deliverables and goals are met.
Oversee the program level clinical operational activities to ensure timely deliverables and milestones are met across various functional groups (e.g., CRO vendor, suppliers, Clinical study teams, etc.).
Directs, manages and/or mentors Global Clinical Operations staff with the overall responsibility and accountability for the assigned program area and relevant staff.
Partners with Global Development Medical Team to strategize key program activities and ensure alignment across functions.
Interacts with executive level management both internally and externally to ensure deliverables are met, negotiate difficult matters and influence policymaking bodies both internally and externally.
Requirements for Director Clinical Operations, Global role:
Bachelors Degree plus 14 years relevant clinical operations experience within a pharmaceutical, biotech or relevant CRO. Masters or Doctorate Degree is preferred.
Proven experience at, or oversight of, clinical research suppliers (CROs, central labs, imaging suppliers, etc.) at a portfolio and functional level.
Proven experience leading Clinical Operations related activities within large, matrixed, global teams and participate/lead at the cross-enterprise level.
Proven experience and a record of strong line management and supervisory experience of senior managers and/or associate directors.
Proven experience designing, leading and being a champion for cross-functional projects with stakeholders and suppliers.
Experienced in negotiating large volume contracts with suppliers on behalf of Global Clinical Operations department.
Experienced in managing challenging situations, including performance issues requiring personnel/supplier termination.
Experienced in utilizing scientific and development knowledge to anticipate and address Clinical Operations related challenges during clinical study execution.
For further details, please contact Larry on +353 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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