Volastra Therapeutics, Inc. is a biotechnology company based in New York City, formed from the laboratory of Dr. Lewis Cantley, along with Drs. Olivier Elemento and Samuel Bakhoum. Volastra is dedicated to the discovery and development of treatments for patients with cancer. The Company’s therapies will target novel pathways and apply insights gained from its scientific founders into chromosomal instability (CIN) and its clear association with the formation, progression, and maintenance of disease. Our lead program, a KIF18A inhibitor, is on track to enter the clinic in the second half of 2023 for patients with advanced cancer.
Volastra has raised funding from top US and European venture firms, including Vida, Polaris, Droia, and Arch, and has a multi-year up to $1.1B drug discovery collaboration with Bristol Myers Squibb leveraging Volastra’s proprietary CINtech platform to identify CIN-related targets. In addition, Volastra has a partnership with Microsoft to develop AI technologies for the interrogation of CIN. The company has a world class advisory board as well as a highly experienced senior leadership team. The company operates out of 15,000 square feet of office and state-of-the-art laboratory space in West Harlem, New York City, within easy traveling distance of Columbia, Cornell, Memorial Sloan Kettering, and most other areas of the city, Westchester County, and New Jersey.
Please visit www.volastratx.com for more information
The role of Clinical Project Manager/Senior Clinical Project Manager will report to the Director, Clinical & Business Operations, and work collaboratively across functions to manage clinical activities that will bring novel cancer therapeutics to patients in need. The Clinical Project Manager/Senior Clinical Project Manager will be assigned to one or more clinical trials and be responsible for the day-to-day operations of the trials. The ideal candidate is self-motivated, curious, detail oriented, works collaboratively and has highly relevant experience.
Volastra is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop with the organization.
- Plans, implements and monitors progress of assigned clinical trials from start up to closeout
- Collaborates with cross functional study team to execute clinical study deliverables
- Provides oversight and management of CROs and vendors
- Develops and manages tools to track clinical study progress
- Ensures compliance with SOPs, GCP and other applicable regulations
- Escalates study-related issues as appropriate
- Coordinates meetings with investigators, sites, consultants, etc.
- Prepares and provides clinical study updates
- Participates in development of study documents and plans
- Reviews and approves study plans generated by CROs and vendors
- Reviews site informed consent drafts, agreements, and budgets
- Proactively identifies risks and helps to implement mitigation strategies
- Oversees enrollment and retention strategies
- Reviews and approves IP release packages
- Manages IP accountability and reconciliation processes
- Monitors clinical data collection, and reviews clinical data for completeness and accuracy
- Reviews monitoring reports to assess site performance
- Reviews and reconciles study related invoices
- Supports and participates in clinical team initiatives
- Bachelor’s degree in a relevant field
- Minimum of 3 years of relevant industry experience, including at least 1 year in a Sponsor role at a biotech or pharma company
- Experience in management of in house and outsourced clinical trials
- Experience in early phase clinical trials
- Experience in oncology
- Strong working knowledge of ICH GCP guidelines and project management concepts
- Excellent communication, organizational, problem-solving and conflict resolution skills
- Experience working with CTMS, EDC and eTMF systems preferred
- Ability to travel domestically (<10%)
Volastra is a lean team of dedicated individuals working to advance therapies for patients with cancer. As such, individuals will from time to time have the opportunity to work on projects and take on responsibilities that may fall outside his/her scope of work. Job is based in NYC with a flexible option for hybrid work.