Senior Clinical Trial Manager

Company Profile

Rakuten Aspyrian, Inc., is a privately funded clinical stage biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Aspyrian has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Aspyrian plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform.

Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses.

Rakuten Aspyrian is currently sponsoring a global Phase 3 multicenter clinical study for ASP-1929 to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy of ASP-1929 in patients with other cancer types.

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 Senior 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 Clinical Trial management (including site and CRO/vendor management) with previous experience with oncology (head and neck cancer), combination drug-device studies, and global Phase 2/Phase 3 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, 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 key vendors and stakeholders
• Provide input into study plans (i.e., CMP, Communication/Risk Mitigation Plan), protocols/amendments, informed consent templates, eCRF & CRF forms/completion guidelines and site reference manuals/instructions
• Oversee Co-Monitors to ensure site and vendor compliance (including review of monitoring reports, issue escalation, monitor assessment as monitoring visits)

• Review protocol deviations and data listings as needed to ensure sponsor oversight
• Work cross-functionally to ensure appropriate communication to stakeholders within/across study teams at Aspyrian and with vendors
• Review and provide input to vendor contracts, SOWs and assist with invoice reconciliation as needed
• Assist in development of internal SOPs and processes to ensure ongoing compliance and inspection readiness

Desired Education, Skills and Experience

• Bachelor's degree or equivalent in the life sciences or related field
• Minimum 7 years related industry experience
• 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 and

organize/track information

• Strong working knowledge of the drug development process, GCP, ICH guidelines, and FDA

regulations

• Proactive recognition of issues as they arise with resolution and/or appropriate escalation to

management 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 20% 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.

Rakuten Aspyrian 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.