RETAINED SEARCH: Head, Clinical Operations, Global Oncology Biopharma:
Newly created position, Lead team of 30+, Boston/Cambridge Area
Our client is a stable and growing Global Biopharmaceutical Company focused in innovative Oncology Drug Development across Phases I, II and III. This is a newly created senior-leadership role responsible for centralizing leadership and management of all aspects within the Clinical Operations (Trial Management, Data Management, etc.) department to include oversight and strategy across all Clinical Development Programs. You will be responsible for people management, cross-functional management, executive-level collaboration, strategy, vendor relationships, compliance, budgets/resources, etc. Our client is a Company that offers the “best of both worlds,” i.e. working for a very well financed Company that maintains an agile “start-up” culture: makes quick decisions and fosters a collegial environment. Furthermore, our client has historically offered favorable compensation/relocation packages to attract top talent.
Features about this Opportunity:
Unique: This is a newly created role in which you will have the opportunity to lead and centralize the Clinical Operations group as the first Head of Clinical Operations for the Company.
Impact: You will work directly with Executive Management and have the opportunity to make a meaningful impact from day one.
Leadership: Direct and lead a team of 30+ Clinical Operations professionals (Trial Management, Data Management, etc.).
Science/Pipeline: Company is considered a major leader on the R&D forefront within their particular Oncology therapies. This includes multiple later stage programs.
CEO’s track record: CEO has a strong track record of success in both large Pharma and Biotech.
Location: Boston/Cambridge area
- Clinical Operations ownership, oversight and strategy across both US and international studies.
- Manage all clinical operations personnel (30+) to include both direct report management and team interaction/collaboration.
- Lead CRO management/relationships, considering appropriate KPIs and metrics.
- Lead budget, resource and timeline management across the entire Clinical Operations department.
- Provide critical operational input into study protocol design through collaborating with Medical and Scientific senior leadership.
- Implement and execute operational input into clinical development plans.
- Review, create, and improve Clinical Operations processes and SOPs.
- Liaise/collaborate effectively across Clinical Development, Regulatory Affairs, Project Management, Drug Safety, Medical Affairs, Quality/Compliance, etc.
- Interface with the FDA and other international regulatory agencies.
- Ensure effective, efficient and compliant conduct of all clinical trials.
- Review and revise study outlines, protocols, amendments and investigator brochures.
- Foster an environment of productivity, results, communication, creativity and team work.
- Establish rapport with clinical investigators and internal teams with the goal of execution of clinical programs/studies according to GCP guidelines.
- Participate in cross-functional project teams and present information internally and externally.
- Spearhead Clinical Operations department process improvements/metrics.
- BS/BA is required. MS/MA is desirable.
- 12+ years of relevant Clinical Operations experience within the Pharmaceutical and or Biotech/Biopharma Industry.
- Prior experience managing and motivating direct reports.
- Track record of managing several projects/programs simultaneously.
- Experience in US FDA regulated Phase III clinical trials required, additional international experience preferred; Phase III clinical trial experience at a study sponsor in drug/biologics development that lead to product approval is preferred.
- Comprehensive knowledge of Good Clinical Practices (GCP), ICH Guidelines, FDA and other international regulatory body requirements.
Thomas Fascia, Partner
email@example.com – P 973-656-0220 x717
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Key Words: Vice President, Executive Director, Senior Director