Biomarker Technology and BST Lead, Associate Director, BST

About the role :

Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below.

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

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.

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

Objective / Purpose :

• The Bioanalytical and Biomarker Sciences and Technologies (BST) department at Takeda is seeking a strong scientific leader to join the group as a biomarker development or bioanalytical expert with experience in one or more technologies including immunoassay, cell-based assays, flow cytometry, LCMS, and / or genomics, to support the clinical development of novel therapeutics across a range of disease areas including oncology, immunology, gastrointestinal, neuroscience.
• The person in this role will work closely with biomarker and bioanalytical SME, study logistics, and therapeutic area aligned and functional leaders within BST, as well as partners and stakeholders in translational medicine and on the clinical teams to progress clinical assets.
• The role will have responsibility for creating and communicating a clear vision for biomarker development and implementation in support of a diverse portfolio across diverse technologies.

They will have a deep understanding of their programs and all deliverables.

The candidate will support context of use-based biomarker development, fit for purpose assay validation, clinical feasibility assessments, and implementation strategies to deliver key assays and data to clinical trials to facilitate decision making across the portfolio.

Accountabilities :

• Candidate will provide strategic, technical, and regulatory expertise in biomarker development and implementation and will have a broad understanding of biomarker technologies and applications in the support of clinical trials.
• The person in the role will lead a BST team of subject matter and logistics experts and will coordinate and ensure execution of BST deliverables in accordance with study timelines.

They will represent BST at cross-functional project teams and keep BST leadership informed of progress.

• An important requirement for this position is the ability to apply fit-for purpose principles in biomarker development and validation to support decision-making on programs.
• The candidate will provide input into applicable sections of clinical documents, consolidating feedback from SME, including study protocols, regulatory documents and communications (IND, NDA, BLA, PMA, etc.

Briefing Book (BB), Investigatory Brochure(IB), Clinical Study Reports (CSR), study start up (e.g. ICF, data transfer agreements) and data base lock activities (e.

g. sample reconciliation, data review / QC and transfer), etc.

• The incumbent will influence and inspire scientists in the organization, work effectively in the matrix environment, and maintain a culture that encourages innovation, scientific rigor, and growth opportunities.
• Success in this role will be evaluated by the ability to build effective partnerships with relevant colleagues within BST and across Takeda, and align and deliver on BST deliverables with a focus on high-quality and timely delivery of biomarker and bioanalytical data for ongoing clinical trials.

DIMENSIONS AND ASPECTS

Technical / Functional (Line) Expertise

• Deep understanding of biomarker development and implementation and expertise in at least one technology area with 10+ years' experience in the biotechnology or pharmaceutical environment.
• Outstanding expertise in one or more biomarker technologies, such as immunoassays, genomics, flow cytometry, others with a current understanding of scientific advancements.
• Ideally, experience within GI, immunology, neurology and / or oncology therapeutic areas, and experience supporting novel modalities.

Leadership

The incumbent will serve in a leadership capacity on BST teams helping drive scientific excellence, strategic, tactical and fiscally responsible operations in support of BST and programmatic goals.

Decision-making and Autonomy

• Independently manages workload and expectations
• Scientifically independent
• Scientific driver for research strategy that impacts group internally and outside area of function

Interaction

• Initiates and leads external interactions and collaborations
• Frequent contact with internal and external personnel at various management levels

Innovation

Makes strategic recommendations for relevant biomarker technologies and outputs in alignment with stakeholders.

Complexity

Highly-matrixed environment

Education & Competencies

PhD degree in a scientific discipline with 7+ years experience, or MS with 13+ years experience, or BS with 15+ years experience

This position is currently classified as hybrid by Takeda’s Hybrid and Remote Work policy

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

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