Scientific Director, Pathology

Takeda Pharmaceutical Company Limited; Boston (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda Pharmaceutical Company Limited is seeking an experienced Director-level Pathology leader to embed AI/ML-enabled digital pathology into nonclinical research workflows in Boston, MA. You will guide cross-functional teams, integrate pathology insights into program governance, and oversee regulatory documentation from IND to NDA.

The role requires a DVM (or equivalent), Ph.D., and board certification, with 10+ years in pharma drug development and strong leadership, communication, and

Qualifications

• DVM (or equivalent) and Ph.D. degree are required.
• Board certification by ACVP/ECVP/JCVP is required.
• Proficiency in veterinary anatomic and/or clinical pathology.
• 10+ years pharmaceutical drug development experience including project team representation.
• Experience with AI/ML pathology tools and digital endpoints is desired.

Responsibilities

• Serve as NCSP Project Pathologist and/or Project Toxicology representative on project teams within Global Pathology (NCSP).
• Lead pathology contributions to target validation and mechanism-of-action understanding.
• Provide scientific leadership for qualification of AI/ML pathology tools and digital endpoints.
• Provide pathology direction for IHC, ISH, and spatial endpoints with iPath and iTox labs, DMPK, and Drug Discovery Units.
• Perform integrative primary reads and peer reviews of animal tissues and communicate findings to study reports and regulatory documents.
• Author and review regulatory documents (BB, IND, IB, DSUR, BLA, MAA, NDA, JNDA) for accuracy and regulatory adequacy.

Skills

Leadership

Communication skills

Decision making

Problem solving

Data analysis

Interpretation

AI/ML pathology

Collaborative leadership

Education

DVM (or equivalent)

Ph.D.

ACVP/ECVP/JCVP board certification

Tools

Halo-link

Halo

Visopharm

Patholytix

Pristima/Provantis

Benchling ELN

Job description

Job Description

Objective / Purpose:

• This role provides scientific and strategic leadership to embed AI/ML-enabled pathology and digital pathology capabilities into Takeda's nonclinical research workflows.
• This role will work with the NCSP iDigPath team to advance AI/ML applications that enable quantitative, high-content analysis of pathology data to improve sensitivity, reproducibility, and translational relevance of tissue-based endpoints to contribute to the validation of novel targets, guide the design of efficacy and safety assessment strategies, and ensure robust integration of pathology insights into program advancement and governance decisions.
• This role will implement workflows to integrate digital pathology into target validation, efficacy and safety assessment strategies to support program advancement and decision-making, primary evaluation and peer review of pathology specimens and data and study reports.

Accountabilities:

• Serve as an NCSP Project Pathologist and/or Project Toxicology representative on project teams within Global Pathology (NCSP), providing anatomic/clinical pathology and toxicology expertise and collaborating with project and cross-functional R&D leaders to support transition of programs into development.
• Lead pathology contributions to target validation and mechanism-of-action understanding through integrated interpretation of pathology, pharmacology, and biomarker data.
• Provide scientific leadership for fit-for-use qualification of AI/ML pathology tools and digital endpoints on efficacy, translational and toxicology studies, including governance for data quality, and model performance.
• Provide scientific direction and pathology expertise for IHC, ISH, and spatial endpoints, in collaboration with NCSP Investigative Pathology (iPath) and Toxicology labs (iTox), DMPK, and Drug Discovery Units.
• Perform integrative macroscopic and microscopic primary reads and peer reviews of animal tissues from toxicology, investigative, translational, and discovery studies to effectively communicate pathology and safety data (and implications) to broad audiences via study reports, regulatory documents, and project meetings; provide recommendations that inform project strategy and decisions.
• Author and review regulatory documents (BB, IND, IB, DSUR, BLA, MAA, NDA, JNDA) for technical accuracy and regulatory adequacy and provide response to health authorities on toxicology/pathology issues, ensuring consistent, defensible scientific positions.
• Represent Takeda in local/national toxicology/pathology meetings and participate in professional society committees, working groups, and cross-industry consortia.

Education & Competencies (Technical and Behavioral):

• DVM (or equivalent) and Ph.D.
• Board certified by the American College of Veterinary Pathologists (ACVP), European College of Veterinary Pathology (ECVP) or Japanese College of Veterinary Pathology (JCVP).
• Proficiency in veterinary anatomic and/or clinical pathology
• 10+ years pharmaceutical drug development experience including as a project team representative and due diligence activity.
• Experience with alternative modalities specifically including oligonucleotides, antibodies and conjugates, small molecules and alternative routes of administration is desired.
• Strong decision-making, complex problem solving, critical data analysis, and interpretation.
• Excellent communication skills (written and oral).
• Ability and desire to take on leadership roles.
• Working knowledge of digital pathology platforms (Halo-link, Halo, Visopharm, Patholytix, Pristima/Provantis and Benchling ELN) and quantitative image analysis workflows
• Track record of leading innovative or transformational initiatives, particularly in digital pathology, computational biology, or translational science
• Strong leadership, collaboration, and mentoring experience consistent with a Director-level role

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:

$177,000.00 - $278,080.00

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

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.