Work Location: remote (working on Pacific Standard Time)

Status: Full-Time

Department: Global Clinical Operations

Pay range: $165-170k+

Company Profile

We are a global biotechnology company developing precision, cell-targeting investigational therapies on our propietary platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally 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.

We are committed to our mission to conquer cancer and aim to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, We have 5 locations in 4 countries, Japan, the Netherlands, and Taiwan.

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 5-10 years of experience with clinical trial management (including site and CRO/vendor management) with previous experience with oncology (head and neck cancer preferred), combination drug-device studies preferred, 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

Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements.

Oversees performance of junior-level clinical operations team members in either a matrix management model and/or as direct reports on their management of study deliverables, and actively provides operational direction and/or general supervision.

Develop and manage study budget and timelines with clear assumptions

Track overall spend for the study over the course of the study

Develop and manage study timelines which includes ability to assess project risks and facilitate appropriate forums with the study team to establish risk mitigation plans.

Manage study-related vendors including CROs and contract labs

Serve as point of contact for key vendors and stakeholders

Responsible for ensuring development and implementation of applicable study plans (i.e., CMP, Communication/Risk Mitigation Plan), protocols/amendments, informed consent templates, eCRF & CRF forms/completion guidelines and site reference manuals/instructions.

Manage Investigational Product (IP)

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 Rakuten Medical 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

Provide frequent study updates to senior management upon request requirements.

Attention to detail and ability to prioritize tasks to meet critical deadlines

Able to collaborate effectively with the study team, cross-functional team members, and external partners.

Support and manage 1-3 clinical studies

Desired Education, Skills and Experience

Bachelor’s degree or equivalent in the life sciences or related field

Minimum 5 years related industry experience with large company or 10 years with smaller company

Experience with global clinical studies

Experience managing study timelines

Previous experience with oncology (ideally head and neck cancer) and/or combination drug-device studies is preferred

Previous experience managing vendor contracts and budgets

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, MS Project or other timeline management tool, 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.

#LI-DD

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.