Associate Director, Genomics, BST

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Job Description

OBJECTIVES/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 expert to support genomics-based biomarker assays/technologies to support the clinical development of novel therapeutics across a range of disease areas including oncology, immunology, gastrointestinal, neuroscience. 
• The incumbent will develop and drive genomic biomarker strategies for preclinical and clinical programs through cross-functional collaboration. The candidate may also serve as a BST Lead for programs, leading execution of BST deliverables across a program and interfacing with cross-functional teams.
•  The person in this role will oversee the implementation of genomics-based biomarker assays/technologies to support the clinical development of novel therapeutics. 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.
• The candidate will support an innovative, industry-leading genomics function responsible for establishing and piloting innovative genomics technologies working with high-quality external genomics partners.

ACCOUNTABILITIES

• The candidate will develop and drive genomic biomarker strategies for preclinical and clinical programs, and oversee assay development, fit-for-purpose validation/qualification, tech transfer, implementation, data delivery, and support contextual data interpretation from innovative and standard genomics assays (NGS, PCR, ddPCR, RNASeq, Nanostring, single cell analysis, spatial transcriptomics and other genomic-based assays).
• The candidate will evaluate, select, and oversee high-quality external genomic labs to ensure the successful design and execution of clinical assays, including validation, longitudinal performance, and data quality.
• The candidate will oversee assays run under regulated approaches (GLP, GCP, GCLP, CAP/CLIA) and QC data to support primary, secondary, and exploratory clinical trial endpoints. The person in the role will support clinical and translational sub-teams overseeing the end-to-end workflows from sample collection, processing, and analysis through data generation and delivery.  
• The candidate will provide input into applicable sections of clinical documents including study protocols, regulatory documents and communications (INDs, NDAs, BLAs, PMAs, etc.), Briefing Book (BB), Investigatory Brochure (IB), Clinical Study Reports (CSR), SMP, ICF, DTA, lab manual, etc.​
• They will collaborate with translational, computational, and other applicable scientists to design experiments that leverage genomics data and to interpret data in context with other clinical data supporting clinical drug development.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Deep understanding of genomics-based biomarker development with 8+ years of experience in the biotechnology or pharmaceutical environment,
• Strong scientific background and experience with assay development and validation across technology platforms in genomics, especially those that are employed in clinical trials (e.g. NGS, WES, WGS, RNASeq, PCR, ddPCR and Nanostring).
• Experience with outsourcing and working with external partners to develop/transfer assays, oversee data generation/analysis and delivery of high-quality data from global clinical trials under regulated settings (GLP, GCP, GCLP and CAP/CLIA etc.).
• Experience within GI, immunology, neurology, and/or oncology therapeutic areas, and experience supporting novel modalities.

Leadership

• The incumbent will Serve as a subject matter expert on BST teams, driving scientific excellence and strategic operations.

Decision-making and Autonomy

• Independently manage workload and expectations.
• Act as a scientific driver for research strategy impacting the group and beyond.

Interaction

• Initiate and lead external interactions and collaborations.
• Maintain frequent contact with internal and external personnel at various management levels.

Innovation

• Make strategic recommendations for relevant biomarker technologies and outputs.

Complexity

• Work effectively in a highly-matrixed environment, navigating complex organizational structures.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• PhD in a scientific discipline with 6+ years of experience, or MS with 12+ years of experience, or BS with 14+ years of experience.
• Extensive drug development experience, preferably in a relevant therapeutic area.
• Strong scientific background in genomics technologies, biomarker development, and regulatory guidelines.
• Excellent communication and collaboration skills with the ability to influence and inspire within complex, matrixed environments.
• Enterprise mindset with strong cross-functional partnership capabilities.

ADDITIONAL INFORMATION

• This position is hybrid as per Takeda’s Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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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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