By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Bioanalytical and Biomarker Logistics Lead in our Cambridge, MA or San Diego, CA office. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

The Bioanalytical and Biomarker Logistics Lead is an exciting, high impact role within the Biomarker Science and Technologies (BST) department within Preclinical and Translational Sciences (PTS) at Takeda. You will work with stakeholders within BST, PTS, and with partners across the business including Clinical Pharmacology, Clinical Operations, Procurement, R&D and IT Quality, and Clinical Data Solutions to support clinical bioanalytical and biomarker operations and logistics with external vendors thereby helping create high quality clinical data.

POSITION ACCOUNTABILITIES

• The Bioanalytical and Biomarker Logistics Lead will forge and manage strong relationships with multiple external specialty testing labs and bioassay vendors, biomarker specimen management and tracking, ensuring clinical sample testing and biomarker data management.
• Function as important contact with external laboratories, with oversight responsibilities for the development of agreements, statements of work, sample analyses, data transfer specifications and data transfer agreements.
• Work with Procurement, R&D Quality Assurance, and IT to qualify and onboard new specialty lab vendors. This will involve submission, support, and follow through of audit requests.
• Solicit and review Scope of Work documents and work with Procurement and other partners to produce contracts.
• Coordinate the bioanalytical and biomarker specimen strategy within multiple clinical programs observing the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/GLP.
• Work with study teams to develop clinical sample management plans.
• Review and contribute to clinical study protocols, informed consents, and central laboratory documents to ensure quality and accuracy.
• Ensure biomarker specimen handling and processing steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of patient samples. Ensure standardization and harmonization of end-to-end biospecimen activities across clinical trials; maximize biomarker specimen accrual and quality.
• Plan, coordinate, and oversee all operational activities required to manage the lifecycle of bioanalytical and biomarker specimens (oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation, and final sample disposition).
• Identify stakeholders for questions impacting clinical samples and escalate issues to provide a resolution.
• Use tracking systems such as Labmatrix to report progress, address issues and resolutions.
• Interface with data standards and data management teams to ensure biomarker data standards are defined for each readout in data transfer specification (DTS) and that approved controlled terminology is used within clinical study protocols.
• High level management of study and assay timelines, tracking of critical path activities, and risk/mitigation planning as needed to ensure successful data delivery and meet study timelines

EDUCATION, EXPERIENCE, KNOWLEDGE, AND SKILLS

• BS, MS or PhD in Biochemistry, Biology, Medical Technology, Immunology, Pharmacy, or related pharmaceutical sciences.
• BS (11+). MS (9+) or PhD (3+) years of relevant work experience in drug development, sample/biospecimen management or clinical trial project management.
• Knowledge of drug development, clinical trial principles and understanding of the role of bioanalysis and biomarkers in clinical studies.
• Experience in sample management activities across multiple projects.
• Ability to work with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support product strategy.
• Excellent written, organizational, and interpersonal communications skills to efficiently and succinctly update the stakeholders and internal team members on progress, address questions and issues as well as interface with external vendors.
• Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling. Knowledge of regulations from other regions (e.g., China and Brazil) a plus.
• Experience with Labmatrix or equivalent sample management software is a plus.
• Proven critical reasoning skills including the identification and resolution of complex problems.

Base Salary Range: $130,200 -$186,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

#LI-JT1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Worker Type

Worker Sub-Type

Time Type