BST and Clinical Biomarker Lead, Neuroscience, Associate Director

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Job Description

About the role:

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 BST and Clinical Biomarker Lead, Neuroscience, Associate Director in our Cambridge, MA location.

Objective / Purpose:

• The Bioanalytical and Biomarker Science and Technologies (BST) department at Takeda is seeking a strong scientific leader to join the group as the BST lead to support programs within Neuroscience Therapeutic Area across a range of modalities (e.g. small molecules, antibodies, nucleic acids and more).
• BST Lead will support the clinical development of novel therapeutics by developing translational and clinical biomarker strategies for preclinical and clinical programs through cross functional collaboration with NS Clinical Sciences, NS DDU, Clinical Pharmacology, DMPK and others as well as external experts in the field of Neuroscience
• BST Lead will also oversee implementation of biomarker and bioanalytical strategies in clinical trials by working closely with BST biomarker and bioanalytical SMEs, study logistics and BST functional heads, and will monitor execution and ensure timely fit-for-purpose assay development and validation at CROs and data delivery to support decision making in clinical studies and portfolio progression
• BST Lead will lead Translational and BST sub teams and will collaborate cross-functionally to align on strategy and plans, and assure effective delivery of data to clinical trials to support decision making.

Accountabilities:

• Responsible for developing and driving translational fluid and tissue biomarker strategies for preclinical and clinical programs within Neuroscience TA
• Actively leads collaborations with external clinical and academic experts to support development of biomarker plans; stays current on the state-of-the-art technologies and emerging biomarker concepts
• Responsible for authoring biomarker and bioanalytical sections of clinical documents (with input from BST SMEs), 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.
• Leads BST sub team of subject matter and logistical experts to coordinate execution of BST deliverables to support clinical trials in accordance with clinical study timelines
• Responsible for overseeing implementation of biomarker and bioanalytical plans by working with BST sub team on vendor selection and oversight, contract executions, timely assay development and validation activities, and high-quality biomarker and bioanalytical data delivery to clinical trials
• Represents BST at cross functional teams (GPT, CST, SET) and keeps BST leadership informed of progress

• Collaborates cross functionally