BST and Clinical Biomarker Lead, Neuroscience, Associate Director

By clicking the 'Apply' button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use.
I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 with Clinical Sciences, QCP, Regulatory, DMPK, Research and other functions to support program objectives

• Influences and inspires scientists in the organization, works effectively in the matrix environment, and maintains a culture that encourages innovation, scientific rigor, and growth opportunities.
  

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Deep understanding of biomarker development and implementation in neuroscience TA with 10+ years' experience in the biotechnology or pharmaceutical environment.
  
• Solid understanding of bioanalytical and biomarker strategies, applicable regulatory guidance, clinical trials, endpoints and deliverables.
  

Leadership

• The incumbent will serve as a subject matter expert 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
• Extensive drug development experience, preferably in the Neuroscience TA area
• Strong scientific background in biomarker development, various biomarker technologies, experience with assay development and validation, operational aspects and relevant regulatory guidelines
• Excellent communication and collaboration skills; ability to influence and inspire, preferably experienced in navigating and influencing highly complex and matrixed environments.
  
• Enterprise mindset to enable effective delivery through strong cross-functional partnership

This position is currently classified as 'hybrid' by Takeda's Hybrid and .