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Takeda Pharmaceutical Company Limited
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
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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 an Associate Director, Translational Biomarker Lead Inflammation/ Autoimmune Disease, ECD where you will provide scientific and strategic leadership in developing the translational biomarker strategy, and plans to secure implementation for Inflammation and Autoimmune (AI) diseases programs in clinical and pre-clinical stages of 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) discovery research and physician-scientists and relevant partner lines and functions to identify and validate biomarkers relevant to patients in clinical studies. Responsible for independently developing translational biomarker strategy and 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. Secure implementation and delivery of data. As part of the Translational Biomarker Research team, you will report to the Head of the team and work with the Gastrointestinal and Inflammation Therapeutic Area Unit (GI² TAU).
Partner with GI-DDU discovery research and physician-scientists in designing and executing Translational Research to discover and validate targeted pathways based on human data and define candidate biomarkers for mechanisms 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, discovery research scientists, and non-clinical and other functions to build consensus for a fit-for-purpose biomarker strategy.
Represent Translational and Biomarker Research on Project and Global Product Teams to provide pharmacodynamic, disease and predictive biomarker strategies 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 provide strategic, technical, and scientific leadership for the progression of the 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, PRC documents, CDP, clinical protocols, ICFs 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 Regulatory Agencies, as required.
Establish and maintain a scientific dialog with KOLs and clinical translational experts in medical, academic, and regulatory communities.
PhD or MD/PhD degree in a scientific discipline with 8+ years experience, or
MS with 16+ years experience, or BS with 18+ years experience.
At least 5 years of experience in clinical translational biomarker research.
Outstanding expertise and depth of knowledge within Inflammation and Autoimmune diseases clinical translational and biomarker space. Dermatology, gastroenterology and/or rheumatology experience preferred.
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.
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.
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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, MAU.S. Base Salary Range:
$149,100.00 - $234,300.00The 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.
During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.
Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations
When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.
Meredith Culp - GPM Head & Chief of Staff, Neuroscience Therapeutic Area
Our culture and shared values make us like a family here at Takeda. It doesn't feel like work when you're doing something you love with people you love, and when your outcome is really fantastic.
Alison Handley, Head, Center for External Innovation
The heart of our work
Shining a light on new perspectives
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
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.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.
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