We are Rakuten Aspyrian Inc., a privately funded, clinical stage, Biotechnology Company headquartered 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 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 will 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.
- Lay out general project management activities that can support pre-clinical and clinical bioanalytical studies, CMC, Devices, Regulatory, and clinical (Phase 1) activities. The candidate will define the actions, assign of resources, budget, monitor project status, identify risks, close out projects.
- Facilitate cross-functional coordination on key overlapping areas between Translational Research, CMC, Devices, Regulatory, and Clinical.
- Develop global budget forecasts, budget tracking, and budget inquiry.
- Review and Track statements of work, master service agreements, and quality agreements.
- Write, review, and QC regulatory documents
- Support the regulatory and communication milestones. Coordinate documents and reportsassociated with the studies for internal records and regulatory filings
- Record actions/key points at meeting, including but not limited to translational research anddevelopment, new programs, and clinical meetings.
- Follow-up with action items across company functions.
- Coordinate and manage research studies conducted at contract research organizations (CROs).
- Manage research-related CRO vendor relationships and Perform site visits to monitor CROs.
- Track and organize bioanalytical and tissue samples from clinical sites.
- Write summary reports of projects.
- Other duties as assigned.
- BS/MS degree minimum, PhD preferable
- At least 5 years in research & development with at least 2 years managing projects in industry setting
- Experience managing CROs from RFP to statements of work to coordinating execution
- Experience with project management software
- Demonstrated ability to see the big picture and pay attention to details
- Ability to effectively communicate with different teams and personalities, including translational research, engineering, manufacturing, regulatory, clinical, and administrationProven track record meeting ambitious deadlines
- Exceptional self-management ability
- Proactive in anticipating difficulties
- Quick and excited to learn about different activities at the company
- Willing to travel to CRO sites for study monitoring.
- Outstanding leadership and management capabilities to build, motivate and manage a strong qualityorganization
- Personal alignment with Aspyrian’s values, mission and vision
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.