Join our team, Change the world

Location:Rehovot, 1 Holtzman St. Science Park, Israel

About the Position:

Emendo is developing a transformative gene editing technology to cure genetic diseases. We are looking for a motivated Cell and Gene Therapy Operator to join our team. The successful candidate will take a central part in the development and manufacturing of gene-edited cell therapy product.

The environment is exciting, fast-paced and offers the opportunity to work at the cutting edge of cellular engineering R&D. If you seek a meaningful job, working with great colleagues using cutting edge science – this might be your opportunity.

Responsibilities

• Manufacture a cell therapy drug product in the lab and in the clean room.
• Perform routine QC assays
• Compile QC data for the batch record
• Execute experiments, record, and analyze experimental data

Qualifications & Skills

• A minimum of B.Sc. degree in a relevant field
• Experience of 3-5 years in the cell and gene therapy industry is a must
• Experience in aseptic and tissue culture technics is a must
• Experience with QC is an advantage
• Good working proficiency in English

Apply Here

About the Position:

Job Description:

The Clinical Trial Manager is responsible for the operational management of clinical trials. The main responsibilities are management of early phase clinical trial/s including the direction, planning, execution and interpretation of clinical trials under ICH/Good Clinical Practices. This position requires routine interaction with key internal and external stakeholders, communicating clinical status, escalating issues, and troubleshooting routine inquiries. This position involves both operational strategy and study execution.

Responsibilities:

• Lead the trial and as such, manage internal and external stakeholders.
• Provide Clinical Operations expertise and strategic 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 in several compounds, indications and therapeutic areas.
• Proactively manage CRO in all aspects of study progress from planning to close-out.
• Collaborate cross functionally with the program development functions to deliver trials according to plan and in the highest quality standards.
• Contribute to the development and presentation of clinical trial operational strategy and updates to senior/executive leadership.
• Oversee, manage, and ensure clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
• Contribute to global regulatory submissions (FDA, EMA, and other governing regulatory bodies)
• Develop, review and approve Clinical Quality Documents
• Manage clinical trial budgets, providing ongoing financial reporting and projections.
• Facilitate the development of clinical trial agreements and other relevant documents.
• Contributes and/or authors 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.
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships.
• management, safety management, and study communication plans)
• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.

Experience Required:

• 6+ years of experience in cell and/or gene therapy industry with at least 4+ years Clinical Affairs
• M.Sc. / Ph.D or M.D in relevant disciplines
• Strong knowledge of GCP and regulatory requirements
• Excellent written and oral English communication skills
• Good organizational abilities and attention to details
• Strong decision-making skills
• Ability to work flexible hours and interface with US time zones. 
• Overseas travel (as needed)
• High presentation and interpersonal skills

Apply Here