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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 Scientific Director, Pathology in Cambridge, MA, where you will be responsible for active cross-functional collaboration, interdisciplinary project team participation, scientific leadership in the design and implementation of safety assessment strategies to support program advancement and decision-making, primary evaluation and peer review of pathology specimens and data, preparation and review of regulatory documentation, study reports and manuscripts. You will also be a representation of Takeda at conferences and meetings with regulatory authorities, manage investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees, and participation in cross-industry consortia and professional society initiatives.

As part of the DSRE, Pathology team, you will report to the Senior Director DSRE - Pathology and serve as a project pathologist and/or project toxicology representative to project teams within the Global Pathology group in Drug Safety Research and Evaluation (DSRE) through the provision of anatomic/clinical pathology and toxicology expertise.

How you will contribute:

• Serve as an integral PTS and DSRE member on project teams to collaborate with project and cross functional leaders with R&D to ensure transition of programs into development.
• Serve as a departmental subject matter expert in due diligence teams supporting external collaborations or licensing opportunities.
• Perform integrative macroscopic and microscopic primary reads and peer reviews of animal tissues from toxicology, investigative, translational and discovery studies; interpret observations and determine the biologic and toxicologic significance of clinical pathology, organ weight, necropsy, and histopathology data in the context of other study data.
• Effectively communicate pathology data and other safety data along with their implications to a broad audience in study reports, regulatory documents, and project team meetings and make recommendations for how these data impact the project team strategy and decision making.
• Author and review regulatory documents (BB, IND, IB, DSUR, BLA, MAA, NDA, JNDA) for technical accuracy, regulatory adequacy and respond to health authorities concerning toxicology issues.
• Lead strategies for investigating and de-risking potential toxicology issues.
• Provide scientific direction and pathology expertise to project specific IHC, ISH and spatial endpoints in collaboration with the DSRE Investigative Pathology and Toxicology labs, DMPK, and Drug Discovery Unit translational pathology groups.
• Provide mentorship and/or direct oversight of junior pathologists.
• Participate in local and national toxicology/pathology meetings and represent Takeda in professional society committees, working groups and cross industry consortia.

Minimum Requirements/Qualifications:

• 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.
• 20+ years pharmaceutical drug development experience including as a project team representative and due diligence activity.
• Experience with alternative modalities specifically including RNAi GalNAc, lipid nanoparticles, 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.
• Proficiency with computer systems such as word processing, spreadsheets, databases, knowledge of Halo, Visiopharm, Patholytix or Pristima (or other pathology data capture systems) also desirable.

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” by Takeda’s Hybrid and Remote Work policy. This position requires the candidate to come onsite to Cambridge location minimum 5x/month.

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.

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U.S. Base Salary Range:

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.

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Job Exempt