Kaleido Biosciences is pioneering a novel category of therapeutics, built upon our unique chemistry platform, to systematically modulate the human microbiome for the treatment of disease and the promotion of health. Kaleido was founded by VentureLabs, a unit of Flagship Pioneering which has launched over 25 breakthrough companies including Seres Therapeutics, Indigo, Axcella Health, and Moderna Therapeutics.
The Sr. Clinical Project Manager will be responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor selection and management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals. This individual will join a dynamic, rapidly growing, and highly collaborative team that combines significant drug discovery experience with leading knowledge of microbiome biology and computational approaches and will have responsibility for expanding the scientific reach of the department and for team building and personnel development.
- Collaborate with internal and external team members for the planning and execution of clinical trials.
- Lead/oversee all operational activities to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly.
- Develop and manage project timelines and budgets; help ensure project deliverables are on time and within agreed upon budget and amended accordingly
- Accountable for coordination of planning, initiation, completion, and reporting of clinical protocols within or across programs from team endorsement to reporting.
- Ensure clinical trials meet time, quality and cost targets consistent with the overall Clinical Development Plan.
- Lead the development of and provide input into study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
- Contribute to department process development, such as the development and writing of Standard Operating Procedures (SOPs) and Work Practices (WPs).
- Collaborate with legal and finance (and others, as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, payment terms, etc.)
- Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
- Monitor clinical study site activities and visit sites as needed
- Track, collect, and review clinical documentation for clinical trials or ensure this is being done by CRO
- Minimum B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education.
- At least 7 years of Clinical Trial Management/Clinical Operations experience required. Experience in oncology preferred.
- Must have experience in CRO oversight.
- Excellent Leadership skills; ability to collaborate across disciplines.
- Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
Ability to travel up to approximately 25% of time
Job Type: Full-time
- clinical project management: 7 years