Associate Director Translational Biomarker Lead Inflammation/Autoimmune disease, ECD GI TAU

Boston, MA, United States

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director Translational Biomarker Lead Inflammation/Autoimmune disease, ECD in our Cambridge, MA offices.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

This position requires acknowledged technical and strategic leadership with managerial experience. The primary role is to provide scientific and strategic leadership developing the translational biomarker strategy, plans and to secure implementation for Inflammation and Autoimmune (AI) diseases 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. Responsible for independently developing 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. Secure implementation and delivery of data.

ACCOUNTABILITIES

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 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 and 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 provide 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.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

Outstanding expertise and depth of knowledge within inflammation and Autoimmune diseases translational and biomarker space

Keeps up with the up-to-date scientific advancement (e.g. competitive landscape, new technology, new research portfolio, and new partnership)

Leadership

Has significant organizational leadership responsibility, including primary responsibility leading the TST and representing Translational Biomarker aspects on project teams.

Decision-making and Autonomy

Independently manages workload and expectations

Scientifically independent

Scientific driver for research strategy that impacts group internally and outside area of function

Interaction

Initiates and leads external interactions and collaborations

Frequent contact with internal and external personnel at various management levels

Innovation

Determines methods on new assignments; makes strategic recommendations on projects

Complexity

Operate in matrix environment supporting discovery and development teams

This position is currently classified as "hybrid" by Takeda's Hybrid and Remote Work policy

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

PhD and/or MD degree in relevant field with 10+ years of experience

At least 7 years of experience in translational biomarker research. Managerial experience desired.

Experience in inflammation and Autoimmune diseases.

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

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:

$149,100.00 - $234,300.00

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-term incentives. 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

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