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Director Translational Biomarker Lead Liver disease – MASH fibrosis, ECD GI²-TAU

Boston, Massachusetts
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  • Job Level: Senior
  • Travel: Minimal (if any)

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 R0122758 Date posted 06/17/2024 Location Boston, Massachusetts

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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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Director, Translational Biomarker Lead where you will provide scientific and strategic leadership developing the translational biomarker strategy, plans and to secure implementation for diseases in liver (NASH, AATD, etc.), IBD (Fibrostenotic CD), skin (Scleroderma, etc.) and MASH fibrosis programs in preclinical and clinical stage development. This is a highly visible, strategic and matrixed role, responsible for leading the Translational subteam (TST) partnering with Gastro-Intestinal drug discovery unit (GI-DDU) research and physician scientists and relevant functions to identify and validate biomarkers relevant to patients in clinical studies. You will also independently develop translational biomarker plans as part of the overall Asset Strategy in the Discovery and Global Product Teams through all stages of clinical development and post-market activities. As part of the Gastrointestinal and Inflammation Therapeutic Area Unit (GI²-TAU), you will report to the Head, Early Clinical Development (ECD), GI, and work with GI²-TAU organization.

How you will contribute:

  • Partner with GI-DDU discovery research and physician scientists designing and executing Translational Research to discover and validate targeted pathways based on human data and to define candidate biomarkers for mechanism of action and drug response. 
  • Lead Translational Biomarker strategy development and execution to support the clinical stage portfolio, including biomarker driven clinical study design, implementation of novel technologies and incorporation of biomarker endpoints for decision-making in early-stage clinical trials. 
  • Lead Translational subteam (TST) and matrix leadership and collaboration across multiple functional areas, working closely with physician scientists, clinical leads, clinical pharmacologists, BST and nonclinical and discovery research scientists to build consensus for a fit-for-purpose biomarker strategy.  
  • Represent Translational Biomarker Research on Project and Global Product Teams to provide pharmacodynamic, disease and predictive biomarker strategy and support translational medicine goals of the assigned programs in all phases of clinical development. 
  • Contribute as a key member of the project  teams that provides strategic, technical and scientific leadership for progression of program from discovery research through development and contribute as a subject-matter expert for clinical development and overall asset strategies. 
  • Implement fit-for-purpose validation for all clinical biomarker assays with BST and ensure high scientific  quality of pharmacodynamic, prognostic and predictive biomarker data to drive program decision making. Evaluate and utilize state-of-the-art scientific tools and ensure implementation cutting-edge technology to drive innovation in the execution of biomarker strategy. 
  • Maintain extensive knowledge of the research and development efforts from academic institutions, competitor biopharmaceutical companies and fee-for-service bioanalytical CROs for MASH fibrosis translational biomarker research. 
  • Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols and documents submitted to Regulatory Agencies. 
  • Support Business Development efforts by evaluating potential in-licensing opportunities and serve as a liaison with external companies, organizations, consultants, university representatives, NIH, and with Regulatory Agencies, as required.  
  • Establish and maintain scientific dialog with KOLs and clinical translational experts in medical, academic and regulatory communities. 

Minimum Requirements/Qualifications:

  • PhD degree in a scientific discipline with 10+ years experience , or MS with 16+ years experience, or BS with 18+ years experience.
  • At least 7 years of experience in translational biomarker research. Managerial experience desired.  
  • Experience in inflammation and Autoimmune diseases.  
  • Outstanding expertise and depth of knowledge within Liver disease – MASH fibrosis.
  • Recognized expertise in biomarker discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations.
  • Excellent understanding of drug development, regulatory processes and clinical development.
  • Strong leadership abilities and proven ability to lead a team within a matrix organization as well as work independently.
  • Strong analytical, oral and written communication, problem-solving and interpersonal skills.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

#LI-SGM

#LI-Hybrid

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes
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Where you fit in

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

  • Manage multiple projects

  • Document data

  • 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 pipeline

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.

Learn more

What we believe in

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

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • 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

    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

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

Patient


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.

Exterior of Takeda Building

About our location

Boston, Massachusetts


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