R&D Quality Data AI Science Leader

Job Title : R&D Quality Data/AI Science Leader

Location : Cambridge, MA

About the role:

As an R&D Quality Data AI Science Manager Lead, you will lead the implementation and management of AI and GenAI data products with R&D and enterprise stakeholders, ensuring compliance with company and regulatory requirements. You will provide Machine Learning expertise for complex and large-scale data projects to drive insights and data-driven decision-making. You will serve as a subject matter expert for Machine Learning frameworks and their application in digital and innovation projects in R&D and enterprise. You will report to the Head of Data & Digital R&D Quality.

How you will contribute:

• Develop and implement data models and algorithms to analyze complex datasets related to pharmaceutical quality and R&D.
• Leverage generative Artificial Intelligence (AI) and large language models (LLM) to enhance data analysis, automate processes, and produce insights.
• Collaborate with cross-functional teams to design and accomplish experiments, ensuring data integrity and accuracy.
• Use statistical methods, machine learning (ML) techniques, and LLMs to identify trends, patterns, and insights that inspire decision-making.
• Provide expertise in designing, modeling, and delivering digital projects for R&D, technology teams, and global DD&T experts; understand, advise, and build data flow optimization including data capture, integration, and use.
• Serve as Subject Matter Expert for setting and maintaining GxP standards according to Takeda Software Development Lifecycle (SDLC) policies and QMS, including digital products and new technologies.
• Prepare and present detailed reports and visualizations to partners, translating technical findings into applicable recommendations.
• Lead the integration and advancement of AI technologies in R&D Quality and partner with internal DD&T and DSI teams using current industry trends, latest technologies, and best practices in data science, generative AI, and pharmaceutical research.
• Develop and implement strategic AI programs to enhance QMS and Quality processes.
• Oversee AI-driven projects, ensuring agreement on our goals and delivery timeline.
• Foster a culture of innovation, promoting collaboration, knowledge sharing, and continuous learning across RDQ and enterprise teams.
• Oversee the design and execution of experiments, data analysis, and interpretation to guide decision-making.
• Provide guidance and mentorship to R&D Quality organization and Data Digital Quality team members, promoting their professional growth.
• Communicate and explain strengths and weaknesses of complex computational models and ML techniques to a broad audience from diverse disciplines.

What you bring to Takeda:

• Ph.D. degree in Data Science, Statistics, Computational Biology, Bioinformatics, Computer Science, or a related field with 10+ years experience, or MS with 16+ years experience.
• Minimum of 8+ years of experience applying machine learning/deep learning approaches in the life sciences.
• Experience leading AI-driven projects in a pharmaceutical or biotechnology setting.
• Experience with generative AI and large language models (e.g., GPT-3, GPT-4).
• Familiarity with GxPs, regulatory requirements, and quality standards in the pharmaceutical industry.
• Experience with SDLC and processes for development of pharma R&D platforms; experience with validation/quality compliance requirements.
• Ability to convey complex information to non-technical stakeholders.
• Knowledge of AI technologies in the pharmaceutical industry (>10 years experience).
• Experience in designing, building, or supporting robust, scalable ML or LLM models (>5 years experience).
• Experience with or knowledge of Agile Software Development methodologies would be ideal.
• Experience with or knowledge of GxPs would be ideal.
• Ability to build relationships and collaborate with other Takeda functions and colleagues.
• Capability to provide input to complex decisions that impact overall data products.
• Willingness to seek input from multiple members and stakeholders to drive innovative solutions.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Be required to wear personal protective equipment (PPE) and other clean room garments daily.
• Need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.

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.