Massachusetts Healthcare Jobs

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. 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.

Here, you will be a vital contributor to our inspiring, bold mission.

JOB DESCRIPTION

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Biomarker Operations Lead in our Cambridge, MA office.

Takeda is committed to outsmarting cancer so that more patients may have access to our transformational medicines – a robust precision and translational medicine approach thoughtfully and strategically applied in drug development is of critical importance to achieve this important objective of our Oncology drug development organization. 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. Here, you will be a vital contributor to our inspiring, bold mission.

The Biomarker Operations Lead is an exciting, high visibility, high impact role within the Precision & Translational Medicine (PTM) function in the Oncology Therapeutic Area Unit (OTAU) at Takeda. The desired candidate will work with stakeholders within PTM and cross-functionally with partners in Oncology Clinical Operations, Biomarker Sciences and Technologies, Clinical Pharmacology, Procurement, R&D Quality, and Clinical Data Solutions to support clinical biomarker operations and logistics with external vendors thereby helping generate high quality Translational biomarker data to enable clinical trial success.

POSITION ACCOUNTABILITIES

• The Biomarker Operations Lead will be accountable for robust clinical biomarker operational planning and execution for oncology and cell therapy clinical programs starting from preclinical stage all the way to the closing of the clinical trials. Provides clinical bioanalytical operational support, and if needed, operational support for Companion Diagnosis (CDx) development.

• Coordinates with the clinical study team and delivers biomarker specimen and testing strategy in accordance with the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/GLP.

• Reviews and provides input into clinical study protocols, informed consents and central laboratory documents to ensure accurate and precise operationalization of biomarker strategies.

• In close collaboration with the Vendor Management team, Procurement, R&D Quality Assurance, Global Translational Leads, Clinical Biomarker Leads, Technology Subject Matter Experts, selects biomarker testing vendors for clinical studies with strong scientific and business rationale and a focus on quality.

• Solicits and reviews Statement of Work (SOW) from bioanalytical and biomarker testing vendors; works with Contract Specialist, Business Operations, and Procurement to ensure timely execution of SOWs.

• Functions as key point of contact for multiple biomarker testing vendors. Responsible for forging and managing strong relationships with vendors to ensure timely clinical sample receipt, sample testing and biomarker data transfers to meet downstream data analysis timelines.

• Collaborates with Biomarker Sample Manager and study teams to develop Clinical Sample Management Plan.

• Ensures biomarker specimen handling and processing steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of patient samples. Ensures maximal biomarker specimen accrual and quality.

• In close collaboration with Biomarker Sample Manager and Clinical Operations Manager, accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker specimens, including oversight of sample collection at site, shipment to Central Lab vendor, shipment to testing vendors for analysis, sample reconciliation, and final sample disposition.

• Addresses questions from the clinical CRO or testing vendors as it relates to sample collections and/or queries.

• In close collaboration with Biomarker Data Manager, accountable for the timely finalization of Data Transfer Guidelines, and transfer of data from testing vendors or Takeda (or clinical CRO) to meet clinical trial and translational timelines.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• BS, MS or PhD in Biochemistry, Biology, Medical Technology, Immunology, Pharmacy or related pharmaceutical sciences.

• A total of 8+ (BS), 5+ (MS), or 2+ (PhD) years of relevant work experience in drug development, sample/biospecimen management or clinical trial project management.

• Deep knowledge of clinical trials and understanding of the role of biomarkers in clinical studies.

• 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 working on Japan trials highly desirable.

• Experience with sample management software is a plus.

• Leadership skills and demonstrated ability to collaborate with a diverse group of scientists, clinicians, vendor labs, internal and external teams to support clinical development strategy. Works effectively in a dynamic operational environment with cross-functional stakeholders.

• Excellent written, organizational, and interpersonal communications skills in order to efficiently and succinctly update team members, stakeholders, and management on progress, address questions and issues, as well as interfacing with external vendors.

• Strong attention to details, timelines and quality.

• Works successfully under pressure with tight timelines.

• Proven critical reasoning skills including the identification and resolution of complex problems.

• Eager to grow and develop capabilities.

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.

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

Base Salary Range: 102,200.00 to 146,000.00 Employees may also be eligible for Short Term and Long-Term Incentive benefits. 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.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

Empowering Our People to Shine

Discover more at takedajobs.com

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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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time