South San Francisco, CA · Remote
Are you interested in making a difference each day to evaluate a potential treatment for blood cancers? Imago BioSciences is a public pharmaceutical company with an investigational product in Phase 2 clinical development across multiple indications. We are building our Clinical Operations team to support the next phases of clinical development. Experienced personnel that thrive on collaborative team planning and self-ownership of your designated clinical study will have opportunity to thrive at Imago BioSciences.
We are looking for an Associate Director or Director of Clinical Operations to join our clinical operations team. This team has the leadership and oversight responsibility of all the on-going clinical trials and the planning of future registration clinical trials. Imago BioSciences offers a competitive pharmaceutical industry salary and benefits package.
This role will report to the SVP, Clinical Operations, and will be responsible for ongoing active clinical study, such as the registrational-supportive Phase 2 studies. Our team utilizes a study resourcing model of Sponsor leadership and oversight with a full-service CRO study partner. Prior experience working in the Sponsor role of this resourcing model is a requirement for the candidate’s success.
- A full study, regional study area, or study specialty-vendor leadership and management.
- Creating and managing study master documents (i.e. consent forms)
- Specific areas of sponsor study oversight include, but are not limited to:
- Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
- Constructive review and endorsement of relevant study plans, as applicable
- Study team meeting management and leadership of sponsor input; regular constructive review of meeting agendas and minutes
- Review of outcomes/actions related to protocol deviations review; support the identification of trends across sites and/or the study and accurate categorization and documentation
- Documented review and monitoring of issues, risks and decisions at the study level, appropriate internal escalation, and implementation of mitigation strategies
- Partner with data management to ensure the database completeness, accuracy, timelines and plans have a strong linkage between the program strategy and are tactically met by the CRO/vendors
- Ensure studies and its TMF documents are inspection ready at all time
- Bachelor’s degree, preferably in healthcare or science related field; advanced degree preferred
- 5 – 10 years of experience working on pharmaceutical/biotechnology clinical research study management
- 3+ years of experience working as the Sponsor company with a pharmaceutical/biotechnology product in human Phase 2-4 multicenter clinical studies.
- Familiarity operating in the capacity of sponsor leadership and oversight with a full-service CRO study partner
- Knowledge and experience with all phases of a clinical study (start-up, enrollment, database lock, closeout)
- Flexible to shift work efforts, as needed, to meet activity prioritization across the Imago clinical operational team’s clinical study portfolio
- Enjoy self-organization and self-management to independently drive clinical study tasks.
- Enjoy working remotely and communicating to colleagues via electronic platforms in your US-located home-office. The product clinical operations team is all remotely located.
- Ability to assess for appropriate and timely issue escalation per the communication pathway
- Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
- Fluent business English (oral and written)