Associate Director, Clinical Operations
|Contact Name:||Larry O’Leary|
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research, now has a newly created role of Associate Director of Clinical Operations based in their Dublin office. This role will report to their Head of Clinical Operations.
The successful candidate will provide significant operational input and oversight in planning, initiating, completing and reporting clinical trials across a program or therapeutic area level with an emphasis on late-stage, registration clinical programs to GCP and company SOPs.
The hire will effectively lead Clinical Operation Teams including in-house team members and serve as the key liaison in interactions with CROs, vendors and other suppliers to achieve program and company goals.
Responsibilities of Associate Director, Clinical Operations:
Provide leadership and support for clinical study execution with an emphasis on late stage clinical development according to SOPs.
Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program.
Provide mentorship to staff and take on line management responsibilities for clinical operations staff when called upon.
Oversee the progress of clinical studies and ensure adherence to study protocols, regulatory and internal operating procedures, intended timelines and budget.
Oversee and where necessary take the lead in writing key documents including but not limited to study protocols, investigator's brochures, CSRs, RFPs and study reference manuals.
Work with various in-house functional groups with regards to operational issues of clinical studies including, for example, vendor oversight, safety reporting and processing, study drug supply plans, and clinical monitoring.
Manage the progress of clinical studies and ensure adherence to study protocols, regulatory and internal operating procedures, intended timelines and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and review and act on trending reports.
Disseminate clinical project communications to appropriate functional groups.
Attends strategic planning meetings.
Interacts with MSLs and commercial.
Selection of CRO CRA and study staff.
Requirements for Associate Director, Clinical Operations:
Minimum of a Bachelor of Science degree. Advanced qualification is preferred.
14 years of clinical management experience, including 6+ years of phase 3 study management experience within a pharmaceutical or biotech environment or relevant CRO experience.
Experience and a record of strong line management and supervisory experience of senior managers
Experience leading large global clinical teams ensuring compliance with ICH, GCP and applicable international regulations and guidelines.
Experience with Phase 3 studies and filings to FDA and Ex-US Regulatory Agencies.
Project Planning experience including oversight of study deliverables, budgets and timelines.
Ability to utilize scientific and clinical knowledge to conceptualize study designs.
Ability to write, present and articulate clearly on scientific and clinical issues.
Collaborate and lead cross-functional teams (team matrix environment).
Some travel may be required (<30%)
Please phone 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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