Study Director
Job Details
Milan, Italy - Milan, Italy
Fully Remote
Full Time
Job Details
About us
Champions Oncology provides an end-to-end range of oncology research and development solutions and services that improve the productivity of drug development. As a growing Contract Research Organization (CRO), our work environment is fast-paced, challenging and ever adapting to meet the needs and timelines of our pharmaceutical-clients. Our team is passionate and self-motivated working together to accelerate the challenges of oncology drug development and ultimately improve patients’ lives around the world. 
Job classification and location: Anywhere in Italy, 100% remote. 
Job overview
The Study Director serves as the primary point of contact for Champions vast portfolio of client sponsors regarding scientific design, PDX tumor model selection, and project execution. This role is client facing, requires strong customer focus and an understanding of the needs and timelines of the client. and provides expertise to clients on the uses of the Tumorgraft/PDX mouse platform for preclinical drug testing.
Essential job duties include preliminary client study design in collaboration with the business development team, interaction with the Lab and Facilities Operations teams to coordinate study execution, and preparing study protocols/updates/analyses/reports. Collaborates with the Business Development group to enhance client relationships and facilitate continued business for Champions Oncology. The Study Director will be proactive with regards to client needs for ongoing and future studies, provide excellent customer service and mitigate miscommunications that occur in the preparation, execution and delivery of TOS projects. Additional duties include:
  • Participates as the scientific technical lead in client meetings related to potential and current pre-clinical PDX opportunities.
  • Manages studies with highly technical components and expanded endpoints such as Immunograft and Hematological studies involving ex-vivo analyses.
  • Determines tumor model status and provides study timelines to BD Director for SOWs pending finalization or finalized.
  • Selects tumor source material for generating study mice. Coordinates the implant of models for studies and monitors the each phase of a study
  • Defines client scientific requirements and develops study design and protocols according to IACUC guidelines and operational ability.
  • Recommends tumor model selection based on needs and availability; suggests replacements when necessary.
  • Reviews SOWs to ensure pricing and scope are captured appropriately.
  • Reviews formulation documents and ensures all necessary test agents and standards of care are in stock prior to study initiation.  
  • Organizes kickoff and protocol review meetings with clients and internal staff.
  • Monitors ongoing study data to ensure tasks are being completed and any adverse events are identified and communicated to the sponsor in a timely manner.
  • Issues directives to the lab based on data and protocol endpoints.
  • Performs data and statistical analysis of study data at completion of TOS sponsor studies.
  • Provide weekly updates, data analysis, and final reports to clients.
  • Recognizes revenue for models/studies for Finance through Salesforce.
  • Organizes shipment of samples to the client at the end of a study.
  • Interfaces with Business Development, Operations, and other Champions personnel to successfully coordinate projects from start to finish
  • Identifies and provides resolution to problems involving ongoing TOS studies.
  • Participates and provides feedback in TOS team and TOS Lab Ops/PL meetings
  • Represents Champions in the field at client meetings and scientific conferences.
  • Identifies potential new opportunities and facilitates ongoing discussions regarding new opportunities with existing clients.
  • Deliver customer value in a timely manner, and ensure protocols are accurate
  • Works independently and performs other related duties as assigned.
  • Depth of scientific knowledge around preclinical research platforms.
  • Scientific expertise in molecular biology techniques including those associated with PCR, IHC and cell culture.
  • Experience with analyzing flow cytometry data a plus.
  • Knowledge of project management and oncology research. Knowledge of in vivo oncology models (Xenograft/PDX) required. Understanding of preclinical drug development a plus.
  • Customer service skills, timely decision making, good interpersonal skills and an ability to be persistent while maintaining tact.
  • Must have the ability to balance several priorities simultaneously with high attention to detail.
  • Ability for frequent adaptation, self-organization, accountability.
  • Effective oral and written communication skills are required.
  • Knowledge of Microsoft Word and Excel as well as Statistical Software such as GraphPad Prism.
  • Ph.D. degree in chemical/biological science or project management required.
  • 3 to 5 years of experience in pre-clinical research or a similar position.
  • In carrying out the duties of the job there will be some exposure to fumes and chemical hazards.
  • Duties performed occasionally require exposure to blood, body fluid and tissue.
  • Must be able to lift and move packages weighing up to 50 pounds.
  • Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility
This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.