Head Of Clinical Pathology, Director, Research

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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.

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

• 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 and the Head of the team supporting pathology/IHC biomarkers in clinical development programs across therapeutic areas and modalities.
• The candidate will work closely with the the BST leadership team, program-specific translational teams 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.
• Lead the Clinical Pathology group and provide direction to the team by serving as a Physician Scientist in Pathology who has strong knowledge in current clinical practice in the Gastrointestinal, Hepatobiliary, Dermatology, or other related field.

How you will contribute:

ACCOUNTABILITIES

• Create, communicate and execute upon a clear vision and strategy for the Clinical Pathology group within BST to support delivery of key pathology/IHC assays and data to clinical trials to facilitate decision making across the portfolio
• Oversee the histopathology work for tissue based clinical assay development including, but not limited to single and multiplex immunohistochemistry or immunofluorescence, spatial transcriptomics, digital pathology, and pathology-based image analysis.
• Provides leadership and strategic support to other parts of the Takeda organization, and/or to external collaborators
• Develop organizational culture and capabilities
• Manage resourcing and budget planning for his/her area of focus

DIMENSIONS 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 into 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 effectiveness of execution, and rigor of thought
• Has significant managerial responsibility and oversees 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

Minimum Requirements/Qualifications:

• MD or MD/PhD degree in a scientific discipline with at least 10 years of relevant experience beyond post-doctoral training, including at least 5 years of industry experience.
• Strong experience in inflammatory bowel disease, inflammation, liver fibrosis and/or psoriasis and strong knowledge in current disease diagnostic criteria and standard of care in Hepato-Gastroenterology is a plus
• Several years of experience utilizing technical platforms (e.g. IHC, PCR, or NGS) for clinical biomarker investigation in drug development.
• 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
• Subject matter expert in one of the therapeutic areas, knowledgeable about Takeda’s other therapeutic areas: Neuroscience, Gastroenterology, and/or Rare Diseases is a plus.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

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.

LOCATION:

• The role is based in Cambridge, MA
• Travel requirements may be 5-10%, primarily within the USA

Base Salary Range: $217,000-$310,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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

USA - MA - Cambridge - Binney St

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time