Director, Scientific Logistics and Biobank, Research

At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.

Job ID R0124562 Date posted 06/17/2024 Location Boston, Massachusetts

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’s Privacy 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.

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 bio analytical 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 bio analytical 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 r esponsible 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.
• 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

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’s Privacy 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.

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 bio analytical 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 bio analytical 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 r esponsible 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 e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . 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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Our team at Takeda is tackling some of the most challenging problems in drug discovery and development. As the newest member of our Research team, you’ll conduct purposeful, meaningful work on groundbreaking modalities that may lead to breakthrough drugs.

With our deep investment in next-generation technologies, you’ll have the resources and support to do your best work. As a part of our team, you’ll connect with brilliant minds inside and outside of Takeda. We are committed to collaborating with academia and emerging biotech companies to expand our reach and impact in cell therapy, gene therapy and data sciences.

Our team’s wide-ranging expertise includes medicinal chemistry, genomics datasets, immunofluorescence, high content imaging, flow cytometry, transcriptional profiling, multi-step synthesis, multimodal genetics, pharmacokinetics and much more. Whatever area inspires you, your work will support the progression of an innovative, industry-leading discovery pipeline and make an impact that matters to patients and society.

A career in Research at Takeda will give you everything you need to succeed professionally — and make a difference to patients, people and the planet.

Design and carry out experiments

Mentor other scientists

Along with incredibly passionate colleagues, there’s a clear commitment to invest in the best facilities and the right equipment needed to successfully perform world-class science.

Christina Alves - Head of Biotherapeutics Process Development

I feel especially lucky to be able to work with colleagues across the industry to meet a unified goal.Takeda is paving the way for how research will be conducted in the future.

Daniel Scheibe - Senior Manager Operations, Systems Engineering, Drug Discovery Sciences

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

Integrity

Perseverance

Inclusion

Inclusion

Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.

Collaboration

A strong, borderless team, we strive together towards our priorities and inspiring mission.

Innovation

Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

Top Workplace

Top Workplace

Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer status for 2024.

Work-Life

Work-Life

Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

Empowerment

Empowerment

Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People

Create an exceptional people experience.

Planet

Protect our planet.

Data & Digital

Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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