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Head of Clinical Operations

Position Summary

The Head of Clinical Operations will be responsible for the operational management of early phase clinical trial(s), starting with a Phase 1/2a trial for a peanut allergy therapeutic, and for the delivery of operational activities as defined in the trial outline/protocol and clinical development plan, according to the agreed quality, budget and timelines.

The position requires hands on work and routine interaction with key internal and external stakeholders, communicating clinical status, escalating issues, and troubleshooting routine inquiries.


  • Lead the operational management of the trial - build its operational strategy and be in charge of study execution

  • Provide Clinical Operations expertise and leadership in the evaluation, selection, and management of Global Contract Research Organizations (CROs) and other external vendors to ensure successful First in Human clinical trial implementation and execution

  • Proactively manage CROs and other vendors in all aspects of study progress from planning to close-out

  • Lead study start-up: Identify potential study sites, site selection and facilitate the development of clinical trial agreements and other relevant documents

  • Lead the development, approval, execution and maintenance of all study operational plans (i.e. trial risk management plan, communication plan, monitoring plan, data plan, etc.)

  • Collaborate cross functionally with the program clinical development functions (internal and external stakeholders) to deliver the trial according to plan and in the highest quality standards

  • Oversee, manage, and ensure clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])

  • Manage and ensure the execution of the logistical plan for the trial (trial materials supply, labeling and packaging, etc.)

  • Contribute and/or author the creation and finalization of key trial documentation: Protocols, Informed consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc.

  • Contribute to global & local regulatory submissions (FDA, EMA, IMoH and other governing regulatory bodies)

  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships

  • Provide ongoing clinical trial financial reporting and forecasting

  • Develop, review and approve Clinical Quality Documents

  • Willingness to work on the strategy level and also work hands-on

  • Willingness to work on the strategist level and also work hands-on


  • Minimum 10 years clinical trial operations experience in pharmaceutical, CRO, or healthcare industry - required

  • Bachelor degree in a related scientific field - required; M.Sc. / Ph.D or M.D in relevant disciplines - advantage

  • Experience with study start-up, timeline planning and management and financial management of clinical trials including vendor oversight - required

  • Previous experience in management of domestic (Israel) as well as international clinical trials - preferred

  • Thorough understanding of clinical research principles and process

  • Strong knowledge of GCP and regulatory requirements


  • Excellent organizational and time-management skills

  • Strong interpersonal skills

  • Effective verbal and written communication skills including presentation skills, in English and in Hebrew

  • Team player and able to work independently

  • Ability to work well under pressure and with tight schedules

Position location: Rehovot, Israel + Overseas travel (as needed)

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