Director, Clinical Pathology

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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 three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

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.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Clinical Pathology in our Cambridge, MA location.

Objective / Purpose:

• The Bioanalytical and Biomarker Sciences and Technologies (BST) department at Takeda is seeking a strong scientific and strategic leader to join the group as a clinical pathology expert supporting pathology/IHC biomarkers in clinical development programs across therapeutic areas and modalities.
• The candidate will work closely with the BST Head of Pathology, BST leadership team, program-specific translational teams, Clinical Sciences and key stakeholders across Takeda to support implementation of pathology/IHC biomarkers and delivery of key assays and data to clinical trials to facilitate decision making.
• The candidate will provide direction to the Clinical Pathology efforts by serving as a Physician Scientist in Pathology who has strong knowledge in current clinical practice in the Oncology, Gastrointestinal, Hepatobiliary, Dermatology, or other related field.

Accountabilities:

• Contribute to development and inspire an innovative, industry-leading pathology team responsible for delivery of key pathology/IHC assays and data to facilitate clinical development across Takeda portfolio.
• Establish and pilot novel pathology technologies, identifying and establishing relationships with high quality external pathology partners.

• Advise teams on best practices of biomarker assays/technologies and image analysis systems to advance machine-based learning algorithms for future research.
• Oversee and ensure quality control of the pathology team’s methods and data from internal and external labs to support primary, secondary and exploratory endpoints in clinical trials under regulated approaches (GLP, GCP).
• Review and approve pathology related assay components and interpretation of data in regulatory submissions (INDs, NDAs, BLAs, PMAs etc).
• Conduct exploratory pathology analyses in clinical trials.
• Oversee the histopathology work for tissue-based nonclinical and clinical assay development including single and multiplex immunohistochemistry or immunofluorescence, spatial transcriptomics, digital pathology, and pathology-based image analysis.
• Stay on top of industry trends to identify future pathology gaps and opportunities and develop plans for implementation.
• Manages resourcing and budget planning for his/her area of focus.
• The incumbent will influence and inspire scientists in the organization, work effectively in the matrix environment, and maintain a culture that encourages innovation, scientific rigor, and growth opportunities.
• Success in this role will be evaluated by the ability to build an effective team and partnerships with relevant colleagues within BST, across Takeda, and externally to align and deliver on BST deliverables with a focus on high-quality and timely delivery of pathology/IHC data for ongoing pre-clinical work and clinical trials.
• Lead and contribute to internal clinical biomarker recommendations, external consortia, and internal/external whitepapers for clinical biomarker excellence and publications.

IMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Outstanding expertise and depth of knowledge within pathology; molecular and histopathology techniques.
• Knowledge of clinical pathology workflows and implementation in clinical trials.
• Strong scientific background and experience with assay development and validation across technology platforms in pathology, especially those that are clinically amenable (e.g. IHC, ISH, IF, and multiplex assays).
• Up-to-date knowledge of scientific advancement in pathology including digital pathology and spatial biology.
• Lead scientific due diligence to assess cutting-edge technologies and establish external partnerships as needed, as well as actively publishing in the scientific community external to Takeda.
• Broad recognition for in-depth expertise in a scientific discipline.

Leadership

• Scientific leadership role, setting high standards for effective execution, and scientific rigor.
• Has significant managerial responsibility and oversees a team of scientists within BST.
• Must be able to lead in a matrixed environment and ensure high quality results from individuals not in direct line of management.
• Success in this role will be evaluated by the ability to influence and inspire scientists in the organization, and maintain a culture that encourages innovation, scientific rigor, and growth opportunities.

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.

• Serve as the BST program lead and coordinate all BST activities for programs and act as the liaison with the larger program/clinical teams.

Interaction

• Frequent contact with internal and external personnel at various management levels.
• Build relationships and collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities.
• Collaborate with clinical operations and CRO labs to ensure high quality data delivery.
• Collaborate with translational medicine scientists, computational scientists, and statisticians to perform data mining and interpretation and present the data in project team meetings.
• Initiates and leads external interactions and collaborations as needed.

Innovation Determines methods on new assignments; makes strategic recommendations on projects.

• Subject matter expert in the development and validation of clinical grade assays, as well as assays using various advanced technologies that may not be currently in clinical use.
• Perform evaluation and selection of adequate technologies for establishment of clinical biomarker assays that meet clinical laboratory standards and regulatory requirements.
• Proposes new processes for the group.
• Initiate technology/vendor selection, plan fit-for-purpose assay validation, oversee/review the validation process and report from CRO to ensure that the report meets regulatory requirements.

Education & Competencies

• MD, MD/PhD, DVM or DVM/PhD with 10+ years of experience in pharmaceutical or biotech Research & Development in a pathology related discipline

• Experience in one of the disease areas is required: Oncology, Gastrointestinal, Hepatobiliary, Dermatology
• Experience supporting external partner identification and analytical validation for developing and filing of pathology focused companion diagnostics
• Experience with digital pathology – development of image analysis strategy, approach, systems for capturing digital images, data interpretation. Experience with artificial intelligence (AI) for pathology data interpretation
• Experience in establishing a pathology laboratory function including recruiting, coaching and developing key talent required
• Experience driving pathology innovation to advance drug development
• Exceptional matrix team leader, ability to interface with leaders across the enterprise and project teams to develop long range plans and budgets for clinical biomarker pathology technologies aligned with company objectives, identify, pilot and establish new pathology related technologies to meet drug development needs in Ph 1, Proof of Mechanism/Concept, and in registrational clinical trials

• A track record of sustained, significant scientific contributions as demonstrated by publications, patents, and presentations is required.
• Extensive drug development experience preferably advancing several molecules from phase I to approval and supporting post-marketing/commercial activities.
• Experience with outsourcing and working with external partners to develop/transfer assays and to oversee data generation/analysis and delivery of high-quality data within expected timelines.
• Strong scientific background and experience with assay development and validation as well as complex image and data analysis.
• Familiarity with clinical documents and processes, i.e. clinical protocols, informed consent forms, laboratory manuals, central lab logistics, etc.
• Capable of applying the highest scientific and technical standards for the successful design and execution of clinical assays implemented from early to late-stage clinical programs.
• Strong communication skills, ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments.
• Experience in mentoring scientists in the above, and a proven ability to build an effective organization by attracting, retaining and developing high-caliber scientists.
• Broad and strong network in the industry, biotech, and health authorities.
• Experience with regulatory agency interactions a plus.

ADDITIONAL INFORMATION

Travel requirements may be 5-10%, primarily within the USA

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.

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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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