Clinical Project Manager / Senior Clinical Project Manager

COMPANY

Volastra Therapeutics, Inc. is a clinical-stage oncology biotech company based in New York City, pioneering novel approaches to treating cancer by targeting chromosomal instability (CIN), a unique vulnerability in cancer. Since its founding in 2019, Volastra has grown to support ongoing discovery efforts and a growing clinical organization.

Our lead pipeline programs focus on two distinct inhibitors of KIF18A, a novel therapeutic target. VLS-1488, internally discovered, entered clinical trials in Q4 2023 for the treatment of advanced cancers. Sovilnesib, in-licensed from Amgen in 2023, re-entered the clinic in Q2 2024. Both assets have been granted Fast-Track Designation by the FDA. Volastra is also developing new techniques to understand the biology of chromosomal instability and leveraging these insights to drive forward a preclinical pipeline of therapies against innovative targets.

Volastra is backed by top US and European venture firms such as Arch, Polaris, Vida, Droia, Catalio, and B Capital, alongside strategic investment from Eli Lilly. In addition to venture funding, Volastra has established partnerships with oncology leaders. Our senior leadership team is highly experienced, supported by a world-class advisory board.

We are headquartered in West Harlem, New York City, within easy reach of Columbia, Cornell, Memorial Sloan Kettering, and surrounding areas. Please visit www.volastratx.com for more information.

JOB DESCRIPTION:

The role of Clinical Project Manager/Senior Clinical Project Manager will report to the Associate Director, Clinical Project Management, 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 with opportunities for the ideal candidate to grow and develop with the organization. Individuals will have, from time to time, the opportunity to gain experience with projects outside their direct scope of work.

Job is based in NYC with a flexible option for hybrid work.

RESPONSIBILITIES:

• 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
• Tracks and manages deliverables from 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
• Prepares and provides clinical study updates
• Participates in development/review of study documents and plans
• Reviews and approves study plans generated by CROs and vendors
• Reviews site informed consent drafts
• Proactively identifies risks and helps to implement mitigation strategies
• Implements 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
  
  

REQUIREMENTS

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 (

SALARY RANGE:

Base salary approximately $120,000 – $180,000 which may vary depending on qualifications, experience, and ultimate leveling.