Director, Translational Biomarker Lead, Inflammation/IBD (Cambridge)

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Job Description

OBJECTIVES/PURPOSE

This position requires an acknowledged scientific and strategic leadership with managerial experience. The primary role is to provide scientific and strategic leadership in developing the translational biomarker strategy, and plans to secure implementation for Inflammatory diseases and IBD (Fibrostenotic CD), in the preclinical and clinical stages. This is a highly visible, strategic, and matrixed role, responsible for leading the Translational sub team (TST) partnering with Gastro-Intestinal & Inflammation drug discovery unit (GI2-DDU) research scientists, Gastro-Intestinal & Inflammation Therapeutic Area Unit (GI2-TAU) physician-scientists, clinical sciences, and relevant partner lines and functions to identify and validate biomarkers relevant to patients in clinical studies. Responsible for independently developing translational biomarker plans, aligned with functional leadership, as part of the overall Asset Strategy in the Discovery, Global Product Teams, and Medical sub-teams through all stages of discovery, clinical development, and post-market activities. Secure implementation and delivery of data and interpretation.

ACCOUNTABILITIES

• Partner with GI² DDU research scientists and GI² TAU 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 pre-clinical and 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 provide matrix leadership and enhance collaboration across multiple functional areas, working closely with physician-scientists, clinical leads, clinical pharmacologists, BST, discovery research scientists, regulatory, 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 target engagement/pharmacodynamics, prognostic and predictive biomarker data to drive program decision-making.
• Evaluate and utilize state-of-the-art scientific tools and ensure implementation of 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 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, consortia, 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.

Technical/Functional (Line) Expertise

• Outstanding expertise and depth of knowledge within fibrotic diseases in Inflammatory Disease (Dermatology) and IBD (Fibrostenotic CD) and translational biomarkers applications.
• 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.

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 any combination of the following areas is required: Inflammatory disease (Dermatology, Respiratory, Atopic diseases), IBD (Fibrostenotic CD) biomarkers research.
• 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.

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:

USA - MA - Cambridge - Binney St

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-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 of 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 USA - MA - Cambridge - Binney St Worker Type Employee Worker Sub-Type Regular Time Type Full time

Job Exempt

Yes. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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