Director, Scientific Logistics and Biobank, Research

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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 Director, Scientific Logistics and Biobank, Research in our Cambridge, MA location.

Objective / Purpose:

Enterprise level partner in charge of establishing and overseeing a robust network of specialty labs to support delivery of high quality bioanalytical and biomarker data to clinical programs. The incumbent will provide critical support to the BST organization by maintaining the departmental book of work and budget. The candidate will also serve as a conduit to the broader organization to help develop a framework, best practices, and efficiencies to drive standardization and simplification to enable connection of the translational strategy with operational planning and execution.

Accountabilities:

• The position requires working in close partnership across various Takeda functions including Translational Sciences within each Drug Discovery Unit and/or Therapeutic Area Unit, Clinical Operations, Quality Assurance, Legal, Finance, and Procurement to build effective and strategic relationships.
• Build and manage the BST network of specialty labs to support delivery of high quality bioanalytical and biomarker data to clinical programs, ensuring adherence to the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/IVDR/GLP.
• The candidate will be responsible for developing and maintaining the BST book of work.
• Responsible for overseeing and managing BST direct and indirect budget annually while ensuring financial stability and effective external resource allocation.
• Work with QA on specialty lab vendor activities (new supplier requests, routine audits, technical assessment management, risk/mitigation).
• Work with Procurement on specialty lab vendor activities (onboarding, consolidation, RFI/RFP, pricing)
• Accountable for developing, tracking, and collating metrics related to both BST and specialty lab performance.
• Responsible for specialty lab vendor management at the partnership level (resource management, escalations, governance).
• Maintain MSAs, legal agreements, and contracts related to BST activities, specialty labs, and partnerships.
• Lead the coordination and support of audit and inspection preparation for both Takeda QA specialty lab audits as well as Agency inspections.
• Responsible for communication and to follow-up on any relevant matters related to specialty labs, Procurement, or Quality deliverables at the partnership level.
• Serve as a point of internal escalation for any specialty lab issues or critical path concerns that cannot be mitigated at the team level.
• Responsible for bioanalytical and biomarker outsourcing strategy, vendor oversight, and the strategic management of resources, priorities, study timelines for activities performed within specialty lab and other partnership agreements.
• Partner with BST colleagues to develop efficient processes for execution of bioanalytical and biomarker activities with a solid understanding of Quality Assurance and geographical requirements to ensure vendor compliance and data integrity.
• Participates in initiatives to create efficiencies and drive simplification in the execution of clinical testing paradigms.
  

Education & Competencies

• PhD degree in a scientific discipline with 10+ years experience, or MS with 16+ years experience, or BS with 18+ years experience; 7 years of Industry experience requiried; 7 years of managerial experience required.
• Knowledge of drug development, clinical trial principles and understanding of the role of bioanalysis and biomarkers in clinical studies. 
• Ability to work with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support product strategy. 
• Experience managing multiple bioanalytical and biomarker deliverables for concurrent clinical trials is required and expected to contribute at a broad and strategic level by executing and overseeing the bioanalytical and biomarker strategies in support of Takeda’s drug development projects across all therapeutic areas.
• Candidate should have a working knowledge of various analytical methods including ligand binding assays, LC/MS, qPCR, flow cytometry and immunohistochemistry as well as a working knowledge of fit-for-purpose assay rigor (qualification, validation, etc.) requirements needed to support clinical trial endpoints. 
• Excellent written, organizational, and interpersonal communications skills in order to efficiently and succinctly update the stakeholders and internal team members on progress, address questions and issues as well as interface with external vendors. 
• Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling. Knowledge of regulations from other regions (e.g., China and Brazil) a plus. 
• Proven critical reasoning skills including the identification and resolution of complex problems. 
• Ability to be an effective member of multi-disciplinary project teams.

This position is currently classified as “hybrid” by 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.

For Location:

Boston, MA

U.S. Base Salary Range:

$169,400.00 - $266,200.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time