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Executive Director/Vice President, Clinical Operations
Boston, MA

Our Client is seeking an Executive Director/Vice President, Clinical Operations.  The successful candidate will have significant experience in ophthalmology & Oncology R&D, be a critical member of the Clinical R&D leadership team, and work in partnership with the Executive Medical Directors to lead the operational strategies and execution of Aura’s drug development programs.


Essential functions:

  • Lead the Clinical Operations team in the implementation of clinical development plans to meet corporate goals and objectives.

  • In partnership with the Clinical Project Manager and other Clinical Leadership Team members, contribute to the clinical development plans for each program and for overall clinical development plan for all clinical programs in the portfolio.

  • In partnership with the Clinical Project Manager, responsible for overseeing all aspects of clinical trial conduct with subject matter experts including clinical development, contract vendors, product development, quality and regulatory to achieve all clinical trial goals on time and within budget. 

  • In partnership with the Clinical Project Manager, develop departmental and clinical trial budgets and collaborate with Finance in the overall management and forecasting of these budgets.

  • In collaboration with clinical development, participate and assist in design and preparation of clinical protocols, contribute to other clinical documents such as IB and IND annual reports, and prepare and review key data/results.

  • Oversee the development of clinical trial documents including Clinical Trial Plans, Safety Management Plans, Pharmacy Manuals, informed consent templates, and other Study Procedure Manual contents.

  • Ensure oversight of CROs, consultants, clinical investigators, and vendor management.

  • Stay current with GCP and regulatory requirements in the preparation and review of the clinical submission in the US and EU.

  • Be part of the Clinical Leadership Team.

  • Oversee the development and implementation of clinical processes and procedures including site budgets, investigator payments, protocol compliance reporting, and investigational product management. 

  • Oversee the conduct of periodic clinical review of data entered in the Electronic Data Capture (EDC) system.

  • Facilitate and manage productive team communication and collaboration, both internally and externally.

  • Represent the company in Investigator Meetings.

 

Qualifications:

 

The ideal candidate will offer:

  • A minimum of a bachelor’s degree in the life sciences; MS degree, preferred.

  • 10-15 years of full-time industry experience at Director level or higher, in clinical operations preferred; direct experience managing, planning, organizing, implementing, and completing phase I-III clinical trials.

  • Experience working with small companies in the start-up environment is a strong plus.

  • This person will ‘own’ clinical operations and have a ‘role up your sleeves and get it done’ approach that is critical in biotech.

  • Ophthalmology pharmaceutical experience required and ophthalmic device experience and/or oncology therapeutic experience a plus.

  • Well versed and current in GCP, ICH, FDA, EMA and other relevant regulations and guidance’s that govern clinical trial conduct.

  • A passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams.

 

Location:

Based in Cambridge MA.  20% travel required.  Remote-based candidates will be considered.

Salary: $280k Per Year