Director Translational Biomarker Lead Liver Diseases – MASH and Liver Fibrosis, ECD GI² TAU

Initial Therapeutics, Inc.; Boston (MA); Hybrid; USD 169,000 - 267,000; Full time

Job summary

Join a forward-thinking organization as a Director, Translational Biomarker Lead, where you will spearhead the development of innovative biomarker strategies for liver diseases. In this highly visible role, you will lead a talented team, collaborate with experts in the field, and drive the execution of cutting-edge research that aims to transform patient care. This position offers a unique opportunity to influence clinical development and contribute to groundbreaking therapies, all while working in a dynamic and inclusive environment that values innovation and excellence. If you have a passion for science and a desire to make a difference, this role is for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Tuition Reimbursement

Paid Volunteer Time Off

Sick Leave

Paid Vacation

Qualifications

• 10+ years in translational biomarker research with a PhD or MD/PhD.
• Strong leadership and analytical skills required for team management.

Responsibilities

• Lead the development of biomarker strategies for liver disease programs.
• Collaborate with scientists to validate biomarkers for clinical studies.

Skills

Translational Biomarker Research

Leadership

Analytical Skills

Communication Skills

Problem-Solving

Education

PhD or MD/PhD

MS

BS

Tools

Biomarker Assays

Clinical Protocols

Job description

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 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 liver diseases (MASH, AATD, etc.) 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 Gastrointestinal and Inflammation Drug Discovery Unit (GI² DDU) research scientists and Gastrointestinal and Inflammation Therapeutic Area Unit (GI² TAU) physician scientists and relevant functions to identify and validate biomarkers relevant to patients in clinical studies.

How you will contribute:

• Partner with GI² DDU research scientists and GI² TAU 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 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 or MD/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.
• Outstanding expertise and depth of knowledge within liver diseases translational and biomarker space. MASH and liver fibrosis 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.

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.

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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, 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-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

Job Exempt

Yes