Our client is a biopharmaceutical company. They have asked us to assist them in a search for a Vice President, Clinical Operations.  

Major tasks and responsibilities include:

• Establishes the Clinical Operations function as the company transitions to a clinical-phase biotechnology company.
• Is responsible for the management of all full-time Clinical Operations personnel, as well as relevant consultants.
• Provides leadership in the development of the clinical trial vendor and site management, budgetary and resourcing strategy at both an overall strategic and at a clinical program level.
• Supervises Clinical Operations personnel to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.
• Provides leadership to other Clinical Operations staff, CROs, Consultants and vendors, to ensure Clinical Operational Team or trial/study teams, are managed in alignment with clinical program and company goals.
• Provides Clinical Program updates to the Leadership Team.
• Oversees adherence to and implementation of study protocols, data management systems, clinical site monitoring, quality systems and audits, and study completion.
• Oversees efficient and timely processing of documents to support clinical development activities.
• Is responsible for clinical trial files and maintains clinical inventory intended for distribution to investigational sites.
• Oversees compliance of the clinical trials with privacy laws in the US, EU and other countries globally.
• Establishes and manages clinical trial budgets of the vendors, consultants, CROs and monitoring of expenses versus invoices and deliverables.
• Oversees and participates in the selection of monitoring resources.
• Provides leadership in the development of monitoring strategy for all clinical trials.
• Represents the company at clinical sites and external project meetings as required.
• Is responsible for development, implementation, and oversight of novel monitoring and management approaches.
• Participates in development and maintenance of clinical monitoring SOPs, tools, and document templates.
• Collaborates cross-functionally with Quality Assurance Auditors to resolve systematic monitoring, site and CRO oversight errors detected in audits.
• Interacts with investigational sites, clinical consultants, and other vendors and leads vendor selection for clinical trials.
• Maintains or develops current therapeutic area knowledge and assesses impact of new information on operational strategies.
• Partners across functional lines with Pre-Clinical, Translational, Research, Medical Ops, Regulatory Affairs, Finance, and others as needed.
• Acts as a clinical operations expert by other functions and represents and leads cross functional initiatives.

     
We seek candidates with the following qualifications:

• A Bachelor's degree in a scientific or health-related field is required.
• Requires a minimum of fifteen years of clinical research experience in Clinical Operations.
• Must have a minimum of ten years of experience in the management of clinical trials as a project clinical trial manager at a pharmaceutical/biotech company or CRO.
• A minimum of ten years of prior supervisory experience required.
• An advanced understanding of GCP, FDA regulations and ICH guidelines is required.
• Requires GCP certification.
• Therapeutic area experience in multiple therapeutic fields is preferred.
• Requires strategic leadership experience or proven track record related to leadership of a team.
• Must have strong spoken and written communication skills.
• Must show initiative and a sense of urgency.
• Must be able to work collaboratively.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.