*This role can be based out of San Mateo, CA or San Diego, CA

Company Profile

We are Aspyrian Therapeutics Inc., a privately funded, clinical stage, Biotechnology Company located in San Diego, California. We are focused on advancing innovative science into breakthrough products that provide cancer patients with new treatments to conquer their disease.

We are supported by visionary investors that have the commitment to build a long-term company that integrates research, development and commercialization of cutting edge cancer therapies with the aim to transform cancer treatments. Our mission is “CONQUERING Cancer. For LIFE.”

We are developing therapies based on a novel proprietary technology platform that utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product planned to initiate Phase 3 pivotal clinical testing to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Given the rapid progression of the clinical studies we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.

Position Summary

The Clinical Trial Manager will be a key manager with responsibilities to manage various aspects of clinical trials from study start-up through database lock in coordination with clinical operations leadership. This is an excellent opportunity to join a rapidly growing company to advance novel cutting-edge anticancer therapies into registration trials and later commercialization.

The ideal candidate will have 7+ years of experience with site monitoring and study/ CRO vendor management with previous experience with oncology (head and neck cancer), combination drug-device studies, and/or global clinical trial experience. The candidate will have strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations.

Key Duties and Responsibilities

  • Manage operational aspects of clinical trials from study start-up through database lock asassigned, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements
  • Manage study-related vendors including CROs and contract labs
  • Serve as point of contact for study site staff and investigators
  • Provide input into study-related materials such as protocols/amendments, informed consent templates, monitoring plans, data management plans, eCRF & CRF forms/completion guidelines/source doc forms, lab manuals, and study-related forms and logs
  • Perform site visits (qualifications, initiations, routine monitoring visits, closeouts) and ensurevisit-related documents are generated
  • Review monitoring reports, protocol deviations and data listings to ensure reliable quality data is and has been delivered
  • Manage site payment processes
  • Facilitate site study drug and study supplies orders, and ensure site accountability records are Maintained
  • Participate in clinical operations department administration as assigned, for example:

- Establishing and managing timelines, costs, and quality metrics and ensuring they are met

- Establishing/reviewing department objectives, SOPs, and work practices

Desired Education, Skills and Experience

  • Bachelor’s degree or equivalent in the life sciences or related field
  • Minimum 7 years related industry experience including:

- Site monitoring

- Study and CRO/vendor management

  • ACRP CCRA certification a plus
  • Experience with global clinical studies
  • Previous experience with oncology (ideally head and neck cancer) and/or combination drug-device studies is preferred
  • Previous experience managing vendor contracts and budgets preferred
  • Strong organizational and project management skills, including ability to multitask andorganize/track information
  • Strong working knowledge of the drug development process, GCP, ICH guidelines, and FDAregulations
  • Proactive recognition of issues as they arise with resolution and/or appropriate escalation tomanagement as warranted
  • Excellent interpersonal, written, and verbal communication skills
  • Ability to work independently and in a team environment
  • Detail-oriented
  • Strong computer skills and high level of proficiency with Microsoft Office (e.g. Word, Excel,PowerPoint, Outlook) and Adobe Acrobat programs
  • Ability and willingness to travel at times up to 50% nationally and internationally, depending on trial activities

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Aspyrian Therapeutics Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.

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