Biomarker Discovery & Bioanalytical Lead

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About the role:

Plasma-derived therapies are critical, life-saving medicines, which patients with rare and complex diseases around the world rely on every day. Global demand for these therapies, particularly immunoglobulins, has increased dramatically over the last 15 years, and continues to grow. Takeda is established as second largest provider of plasma-derived therapies (PDT) globally. Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet expectations of patients and health care providers with plasma-derived therapies for patients with immunologic, hematologic, autoimmune and other complex diseases.

Within PDT R&D, Translational Science Team plays a pivotal role in supporting programs from early development to market authorization by being responsible for discovery, non-clinical development, translational & biomarker research, and bioanalytical support of clinical programs. As a Biomarker Discovery & Bioanalytical Lead based in our Cambridge, MA office, you will report to the Lead Translational Science & Platform Technologies.

How you will contribute:

• Perform creative translational research in the area of autoimmune, inflammatory and/or hematological diseases.

• Conceptualize, design, and manage bioanalytical and biomarker assays, assay validation, sample testing, and data interpretation and reporting

• Manage projects across the PDT portfolio and schedule activities in accordance with line function and program/corporate goals/assignments and priorities supporting Discovery, Nonclinical and Clinical programs

• Design Biomarker Plans and Immunogenicity Risk Assessments

• Manage both internal and external work, including interactions with technical and administrative staff at CROs or external vendors

• Implement new approaches and propose new biomarker strategies and bioanalytical plans

• Provide bioanalytical Subject Matter Expert input to teams

• Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publications

• Review assay validation and bioanalytical reports and provide training and mentorship to internal staff

Minimum Requirements/Qualifications:

• Academic degree MSc

• 5+ years of industry/CRO experience in area of biomarker and bioanalytical development

• Familiarity and experience with global regulatory guidelines, expectations and corresponding industry best practices is required (e.g., FDA Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP))

• Experience managing external work at CROs is required

• Experience in large molecule assessments for PK, toxicology and biodistribution studies and ADA and biomarker studies in multiple matrices and tissues (brain, spinal cord, liver, kidney, spleen, lymph nodes) to support both non-clinical and clinical studies

• Experience in molecular understanding of clinical manifestations, therapeutic approaches and current research paradigms in rheumatology, clinical immunology, hematology, gastrointestinal disorders, or hepatic diseases

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• 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 and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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

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.