Head, Clinical Operations (Director, Sr. Director, or Executive Director)

The search is being conducted on an Exclusive Retained Search basis.

Our Focus:  OncologySearch.com is a nationwide oncology-focused recruiting firm seeking candidates for positions involved in Drug Discovery to IND filing to NDA/BLA filing.    Positions levels include:  Scientific - Management - VP - C-level
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Head, Clinical Operations (Director, Sr. Director, or Exe. Director)
 

OUR CLIENT COMPANY

Our client company is a well-established clinical-stage T-cell focused biopharmaceutical company. Their leading drug candidate is uniquely positioned to address key unmet medical needs in immune-oncology and other diseases.   They are partnered with industry and academic leaders to investigate combinations with leading immunotherapeutics and to rapidly expand into additional combinations such as CAR-T.   They are well-funded and rapidly expanding.   We are assisting them in identifying qualified candidates for a Head of Clinical Operations on an exclusive, retained search, basis.

POSITION SUMMARY

The Director/Sr Director/Exe. Director, Clinical Operations will oversee all aspects of clinical trial operations including CRO/vendor selection, contract negotiation, and review and approval of invoice, managing drug supply forecast, developing appropriate SOPs to ensure trial conduction in compliance with regulatory requirements, and providing clinical operations related training to the clinical team. He/she will also be responsible for planning and determining resource needs, finalization of budgets and will work with Senior Management when input is necessary. This position reports to Vice President, Head of Clinical Development.

Responsibilities

• Oversees all aspects of clinical operations and manages resources to ensure study milestones and deliverables are achieved.
• Leads the overall operational aspects of clinical trials.
• Ensures all programs under his/her oversight are conducted in accordance with applicable SOPS, ICH, GCP and other regulatory requirements.
• Provides clinical support for required regulatory submission, such as annual reports, updating of the IB, and final study reports.
• Develops departmental SOPs and works with Quality Assurance for compliance with applicable quality and regulatory requirements.
• Provides routine updates regarding the status of programs to Senior Management.

Requirements/Qualifications

• Provides routine updates regarding the status of programs to Senior Management
• BS/MS degree in a life science, nursing qualification or relevant experience
• Candidate should have a minimum of 7 years’ experience in clinical operations methods and processes in industry setting required.
• Previous management of CROs required.
• Science graduate with a proven track record of oversight, coordination and resource management of multiple global clinical operations deliverables to time, quality and budget.
• Related experience working in the Oncology or Immuno-Oncology therapeutic area
• Excellent working knowledge of ICH, GCP and FDA/EMA guidelines/regulations.
• Exhibiting “can-do” attitude, “out-of-the-box” thinking and good attention to details.
• Excellent managerial, organizational and negotiation skills.
• Excellent verbal and written communication skills.
• Solid understanding of the drug development process with a special emphasis on clinical operations.
• Proven track record of success in a leadership role.
• Energetic individual, eager to manage multiple activities and priorities.
• Dedication to quality in all work tasks and deliverables in a timely manner
• Approximately 10% travel may be required (not applicable during the COVID-19 pandemic).

Relocation Assistance:
Should relocation be necessary, assistance will be provided.

Interested or have questions?
Forward your resume in confidence to or contact Steve Collins via email (Steve@OncologySearch.com).  Should you wish to schedule a conversation with Steve, please visit his call scheduler at:  https://calendly.com/steve4/call

Distributing Your Resume/CV
Your resume/CV will never be forwarded to any person or company without your prior knowledge and approval.

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Disclaimer:      

NOTE:   This is an unofficial document prepared by OncologySearch.com to provide basic information concerning the position.   The company we are conducting this search for has the official job description.