Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology 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.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

Position Summary

Reporting to the Chief Technology Officer, the Senior Manager/Associate Director of Clinical GCP Quality will be responsible for evaluating and mitigating risk of global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan) are desirable.

Key Duties and Responsibilities

Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities.
Successfully lead global and cross-functional quality projects
Maintains current knowledge of ever-changing clinical quality guidance and regulations.
Excellent communication and people skills to ensure cohesive and collaborative teamwork.
Demonstrated ability to implement and collaboratively drive company initiatives and policies.
Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred.
Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close).
Successfully demonstrates ability to both conduct and manage site, internal GCP and vendor audits as well as direct and guide audit follow-up actions.
Establish Quality and Cross-Functional SOPs, processes and associated documents.
Working closely with clinical pharmacovigilance team on supporting clinical trial safety
Responsible for presenting and updating CGP quality review metrics and reporting to Sr. Management
Other duties as assigned.

Desired Education, Skills and Experience

S. Degree in life sciences with advanced degree in a scientific discipline preferred.
Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance.
Minimum of two years of GCP auditing (e.g. clinical site and clinical vendor) as lead auditor experience preferred.
Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents.
Previous experience with oncology, combination drug-device clinical studies, and/or multi-regional with US based clinical trial experience is a plus.
Pharmacovigilance/Safety QA experience is a plus.
Medical Device GCP experience is a plus.
ISO Standard (e.g. ISO13485, ISO9001, ISO27001) understanding is a plus.
Computer System Validation, Software validation & qualification for 21 CFR Part 11 compliance is a plus.
Experiences with Clinical Quality Management on a risk-based approach is needed.
Electronic TMF, document, quality, and learning management systems experience is needed.
Strong organizational and project management skills.
Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment.
Professional working proficiency or above in English

REQUIREMENTS:

Physical Demands

None, other than those necessary to perform the essential job functions

Manual Dexterity

None, other than those necessary to perform the essential job functions

Audible/Visual Demands

Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.

Environment

None, other than those necessary to perform the essential job functions.

Travel

Up to 30%

The expected salary range for this position based in California is $175,000 to $220,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors. Company is posting role confidentially.

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 for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical 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.

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Location (City)

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

When autocomplete results are available use up and down arrows to review

+ Add another education

LinkedIn Profile

Website

Current Address: *

Driver's License Number and State of Issuance: *

Are you willing to relocate? *

Are you at least 18 years of age? If hired, you will be asked to produce proof of age and work permit if necessary. *

Do you require work authorization sponsorship? *

Without telling us which one, are you a United States citizen, noncitizen national, lawful permanent resident, or an alien authorized to work in the United States? *

Do you have any professional qualifications and/or certificates?

If hired, will you have a reliable means of transportation to and from work? *

When are you available to start a new job? *

Desired Salary *

How were you referred for this job? *

Are you currently enrolled in school? *

Please provide the name and location of your high school? *

Did you graduate high school? *

Please provide the name and location of your college or university, if applicable. If none, type "none". *

Did you graduate college or university? *

Please provide the name and location of any graduate school(s) education, if applicable. If none, type "none". *

Did you graduate graduate school(s)? *

Name of present or most recent employer: *

Address of your most recent employer: *

Your title at your most recent employer: *

Duration at most recent employer (from/to - month/year): *

Describe your work at your most recent employment: *

Reason for leaving or considering leaving: *

Name of previous employer: *

Address of your previous employer: *

Your title at your previous employer: *

Duration at previous employer (from/to - month/year): *

Describe your work at your previous employment: *

Reason for leaving previous employer: *

Please describe additional skills or abilities that would relate to this position, to add any additional references, or to explain any answer given earlier. Also, use this space to list any relevant professional organization to which you belong. Please omit those which indicate your race, color, national origin, ancestry, religion, sex, age, sexual orientation, or political affiliations.

I have not knowingly withheld any information that might adversely affect my chances for employment, and the answers given by me are true and correct to the best of my knowledge. I understand that any omission or misstatement of material fact on this application or any document used to secure employment shall be grounds for rejection of this application or for immediate discharge, if I am employed, regardless of the time elapsed before discovery. *

If employed, I understand that I will be an at-will employee, meaning that I may resign at any time for any reason, and the company may terminate my employment at any time, with or without cause. *

Any offer of employment is conditional upon my ability to submit proof of my legal right to work in the United States, satisfactory completion of a background check, and my agreement with, and signature on, the company’s Confidentiality Agreement, i.e.- Non-Disclosure Agreement. *

I hereby authorize the company and its agents, employees, and representatives to thoroughly investigate my references, work record, education, and other matters related to my suitability for employment and, further, authorize the references I have listed to disclose to the organization any and all letters, reports and other information related to my work records, without giving me prior notice of such disclosure. In addition, I hereby release the organization, my former employers and all other persons, corporations, partnerships and associations from any and all claims, demands or liabilities arising out of or in any way related to such investigation or disclosure. *

I understand this Agreement and signed it of my own free will after having been given an opportunity to ask questions which, if asked, were answered satisfactorily and in a manner which I understood. *

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Rakuten Medical Inc. - US’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Are you Hispanic/Latino?

Please identify your race

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Disability Status

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Enter the verification code sent to to confirm you are not a robot, then submit your application.

Security Code *

This application was flagged as potential bot traffic. To resubmit your application, turn off any VPNs, clear the browser's cache and cookies, or try another browser. If you still can't submit it, contact our support team through the help center.

Sr. Manager/Associate Director, Clinical GCP Quality Assurance

Apply for this Job

Voluntary Self-Identification

Voluntary Self-Identification of Disability