VP/Director of Clinical Operations

(Immuno-oncology focus)

 

 
Position #:                      1438
Therapeutic Area:          Immuno-Oncology               
Recruiting Status:          Exclusive Search
Location:                        Montgomery County Maryland
Why Available:               New position
 

Note:   Also seeking two Clinical Trial Project Managers   Link to job description:    Clinical Trial Project Managers

Note:   Also seeking Clinical Development Scientist:   Link to job description:           Clinical Development Scientist

 

POSITION SUMMARY

The VP/Director of Clinical Operations will oversee all aspects of clinical development including data collection, monitoring, safety surveillance, adherence to protocols and compliance with regulatory requirements. The Director of Clinical Operations will also be responsible for the supervision of Clinical Operations staff, the finalization of budgets and will work with senior management when input is necessary.  This position reports to the Chief Medical Officer.

 

Essential Duties & Responsibilities

  • Oversees all aspects of clinical operations and directly supervises all clinical operations staff

  • Leads the overall conduct of all clinical programs.

  • Ensure all programs under his/her oversight are conducted in accordance with applicable SOPS, ICH, GCP and other regulatory requirements.

  • Provide clinical support for required regulatory submission, such as annual reports, updating of the IB, and final study reports.

  • Develop departmental SOPs and work with Quality Assurance for compliance with applicable quality and regulatory requirements.

  • Provide strategic clinical development input and routine updates regarding the status of programs to senior management.

  • Adequately resource, train and develop the clinical operations department.

  • Conduct annual performance evaluations for direct reports

 

Education & Experience:

  •  Degree in a life science, nursing qualification or relevant experience

  • Candidate should have a minimum of 7 years’ experience in the clinical research industry, with a minimum of 5 years direct experience in planning and managing clinical studies.

  • Related experience working in the Oncology or Immuno-Oncology therapeutic area

  • Excellent working knowledge of ICH, GCP and FDA guidelines/regulations.

  • 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
     

Working Conditions

  • Approximately 30% travel may be required


     

NEXT STEP OPTIONS:

 

Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.

 

NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.

 

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