Clinical Biomarker Manager

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Job Description

Clinical Biomarker Manager

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

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.

As a Clinical Biomarker Manager working on the Clinical Biomarkers Innovation and Development team, you will be empowered to oversee the scientific and operational execution of the clinical biomarker strategy in partnership with various key stakeholders within the company and at external laboratories In this role, you will contribute to Takeda’s mission by providing strong program management skills and a passion for clinical drug development to bring novel medicines to patients. A typical day will include:

POSITION OBJECTIVES:

• Responsible for executing the biomarker operations, biomarker strategy and diagnostics plans with excellence for assigned programs including managing biomarker assays at CROs, ensuring CROs meet all key deliverables and timelines.
• Independently provides oversight of biomarker assay performance during clinical study conduct at CROs, ensures CRO maintains sufficient supply of critical reagents for uninterrupted clinical sample analysis, ensures timely delivery of high-quality biomarker data to meet program deliverables, and supports documentation preparation for regulatory submissions.

POSITION ACCOUNTABILITIES:

• The Clinical Biomarker Manager will be accountable for project management and process-related strategies and deliverables for the CBID sub-team and will work closely with the CBID sub-team leader.
• Candidate will work in close partnership with the clinical biomarker, diagnostics, and bioanalytical sciences groups within CBID and across various Takeda functions including Translational Sciences, Clinical Operations, Data Sciences, Legal, Finance and Quality Assurance.
• Candidate should have experience developing and validating biomarker assays using immunoassays (ELISA, MSD, etc) and/or flow cytometry, as well as a working knowledge of fit-for-purpose assay rigor (assay qualification and validation based on clinical context of use) requirements needed to support clinical endpoints. 

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• PhD degree in a scientific discipline with 5 years’ experience, MS with 10 years’ experience, or BS with 12 years’ experience. 5 years of Industry experience required. 
• Advanced project and program management skills/certifications as well is preferred.
• Extensive drug development experience preferably advancing several molecules from phase I to approval and supporting post-marketing/commercial activities.
• Strong scientific background and experience with clinical bioanalytical assay development and validation. Experience with analytical platforms such as flow cytometry, and/or immunoassays is a must. Experience with IHC is desired.
• Experience managing multiple biomarker deliverables for concurrent clinical trials is desired. 
• Expert executive communication skills; ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments with and without authority.

Takeda U.S. Vaccine Requirement:

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

This job posting exclude Colorado applicants.

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.

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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.

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