Head of Clinical Pathology Operations
1 week ago
By clicking the Apply button, I acknowledge that my employment application process with Takeda will commence and that the information I provide in my application will be processed in accordance with Takeda's Privacy Notice and Terms of Use.
I further affirm that all information I submit in my employment application is accurate to the best of my knowledge.
Job Overview:
At Takeda, we are a forward-thinking, world-class research and development organization dedicated to unlocking innovation and delivering transformative therapies to patients.
By concentrating our R&D efforts on three therapeutic areas and other targeted investments, we push the limits of what is achievable to bring life-changing therapies to patients globally.
Recognized as a Global Top Employer, Takeda offers dynamic careers, promotes innovation, and strives for excellence in all our endeavors.
We cultivate an inclusive, collaborative environment where our teams are united by a steadfast commitment to delivering Better Health and a Brighter Future to individuals worldwide.
Are you seeking a patient-focused, innovation-driven organization that will inspire and empower you to excel? Join us as a Director of Clinical Pathology.
Role Objective:
The Bioanalytical and Biomarker Sciences and Technologies (BST) department at Takeda is in search of a strong scientific and strategic leader to join our team as a clinical pathology expert. This role will support pathology/IHC biomarkers in clinical development programs across various therapeutic areas and modalities.
The selected candidate will collaborate closely with the BST Head of Pathology, BST leadership team, program-specific translational teams, Clinical Sciences, and key stakeholders across Takeda to facilitate the implementation of pathology/IHC biomarkers and ensure the delivery of essential assays and data to clinical trials for informed decision-making.
The candidate will provide guidance to Clinical Pathology initiatives by serving as a Physician Scientist in Pathology, possessing extensive knowledge of current clinical practices in Oncology, Gastrointestinal, Hepatobiliary, Dermatology, or related fields.
Key Responsibilities:
Contribute to the development and inspire an innovative, industry-leading pathology team responsible for delivering key pathology/IHC assays and data to facilitate clinical development across Takeda's portfolio.
Establish and pilot novel pathology technologies, identifying and fostering relationships with high-quality external pathology partners.
Advise teams on best practices regarding 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 laboratories to support primary, secondary, and exploratory endpoints in clinical trials under regulated approaches (GLP, GCP).
Review and approve pathology-related assay components and data interpretation in regulatory submissions (INDs, NDAs, BLAs, PMAs, etc.). Conduct exploratory pathology analyses in clinical trials.
Oversee 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 informed about industry trends to identify future pathology gaps and opportunities and develop implementation plans. Manage resourcing and budget planning for the area of focus.
The incumbent will influence and inspire scientists within the organization, work effectively in a matrix environment, and maintain a culture that encourages innovation, scientific rigor, and growth opportunities.
Success in this role will be assessed 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.
Qualifications:
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 following disease areas is required: Oncology, Gastrointestinal, Hepatobiliary, Dermatology.
Experience supporting external partner identification and analytical validation for developing and filing pathology-focused companion diagnostics.
Experience with digital pathology development of image analysis strategies, systems for capturing digital images, and 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.
Experience driving pathology innovation to advance drug development.
Exceptional matrix team leader with the 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.
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 collaborating with external partners to develop/transfer assays and 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, including clinical protocols, informed consent forms, laboratory manuals, and central lab logistics.
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 with the ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments.
Experience in mentoring scientists 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 is 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 is committed to equitable pay for all employees and strives to be transparent with our pay practices.
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