Job Description
Our client, a commercial stage Biopharma company with strong development pipeline, now seeks an experienced Associate Director of Clinical Operations Management within their Clinical Operations team based in Dublin working on early and late stage studies.
The hire will effectively lead Clinical Operation Teams at Program level, 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.
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 ideal candidate will be an experienced Clinical Program Manager, working at Associate Director level with depth of experience in providing oversight of clinical operations study team, vendors, etc. working effectively in a fast-paced dynamic environment.
Responsibilities of Associate Director, Clinical Operations Management:
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 Management:
Bachelor of Science degree, advanced qualifications such as Masters or PhD is preferred.
12 years of clinical operations management experience, including 5+ years of phase 2 and 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 CTMs or CPMs.
Experience leading large global clinical teams ensuring compliance with ICH, GCP and applicable international regulations and guidelines.
Ideally experience with both early and late stage studies, including 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 utilise 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 global travel may be required (<20%)
For further details please phone Larry on +353 1-2302400 / larry@rftgroup.ie
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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