• Select and activate chosen study sites, establish and maintain an excellent relationship with site investigators and research teams
• Create and update activities in overall project plan on a regular basis to assure appropriate outcome of clinical trial projects in terms of scope, timelines and objectives.
• Coordination of assigned CRA monitoring activities
• Ensure study quality/GCP compliance to deliver a rigorous patient data
• Partner with Clin Ops Director and provide oversight to all vendors or study delivery team, ensuring timely delivery of milestones and budget compliancy
• Propose and implement study process improvements; Participate in the preparation, updating and training of SOPs
• Liaise with manufacturing, central lab, and other study project stakeholders as needed
• Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans)
• Works with the Clin Ops Team to develop and maintain study timelines
• Responsible for ensuring vendors deliver according to scope of work and review/approve vendor invoices

• Degree in Life Science, biological science, or related area: or equivalent relevant experience acquired within life science industries
• 2-4 years’ experience in project management in early phase oncology/haematology trials, prior small start-up company experience in biotechnology highly desirable
• Strong knowledge of ICH and GCP rules and of the complete clinical trials process

• Creative and finding ways to get the job done
• Thriving in challenging environments and finds ways to remove obstacles to complete enrollment and deliver a robust patient data package
• Flexible mindset capable to manage change and deal with ambiguity
• Proven ability to manage complex projects
• Flexibility to re-prioritize workload to meet changing timelines
• Excellent communicator able to raise the profile of clinical studies within sites and create advocates for recruitment
• Autonomous, pro-active and hands on personality.
• Driven to achieving highest results in challenging timeframe
• Efficient in planning and executing work: orchestrate multiple activities at once
• Team player, able to navigate thru a matrix organization in multi-cultural environment

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• Support the team’s efforts to adapt and optimize the base R&D CAR-T production processes to GMP manufacturing and commercial production.
• Design and oversee process research studies (incl. protocol writing, working closely with technicians, data analysis and report writing)
• Coordinate study planning and execution from the Industrialization group with R&D, QC and manufacturing teams
• Evaluate new and alternative raw materials and establish raw material specifications in collaboration with QA and QC
• Contribute to Process Qualifications studies and comparability studies
• Present data to project group and larger multidisciplinary teams including externally at meetings/congresses/conferences as appropriate
• Execute research timelines to meet program and corporate objectives

• PhD in cell biology or related field
• Minimal 3 years post-doctoral or research experience in academia or industry
• Expertise with small and large-scale mammalian cell culture, preferably T-cells, and experience with closed culture systems and cell processing equipment and techniques
• Previous experience with cellular characterization assays including techniques such as, multiple parameter flow cytometry, ELISA’s, and molecular biology experience is required
• Experience with Good Manufacturing Practices (cGMP)
• Experience with writing protocols and reports

• Demonstrated ability to work collaboratively across team functions to achieve project objectives on schedule
• Demonstrated ability to work both independently and within a goal-oriented team
• Excellent communication skills (both written and oral), time management, record keeping and data analysis skills
• Languages: fluency (written & spoken) in English & French, additional languages are a plus
• Hands on personality and passion for bringing operational value to the organization
• Patience, resilience and strong goal-oriented mindset
• High level of autonomy and initiative

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