Bioanalytical Sciences Lead

About the Role:

Takeda is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. Our focus on three therapeutic areas and targeted investments enables us to push the boundaries of what is possible in order to bring life-changing therapies to patients globally.

• Plasma-derived therapies are critical, life-saving medicines, which patients with rare and complex diseases rely on every day. Global demand for these therapies has increased dramatically over the last 15 years, and continues to grow. Takeda is established as the second-largest provider of plasma-derived therapies globally. Leveraging our 75+ year pioneering legacy, we believe there is tremendous potential to meet expectations of patients and healthcare providers with plasma-derived therapies for patients with immunologic, hematologic, autoimmune, and other complex diseases.
• Within our PDT R&D, the Nonclinical and Translational Sciences (NTS) Team plays a pivotal role in supporting programs from early development to market authorization by being responsible for innovation and early discovery, non-clinical development, translational & biomarker research, and bioanalytical assay development to support non-clinical- and clinical-stage programs.

Key Responsibilities:

ACCOUNTABILITIES

• Establishes project direction through integrating science, key technical knowledge, and program objectives.
• Provides leadership to enable project teams to make informed decisions regarding selection and stage-up of discovery compounds for pre-clinical development in Oncology areas.
• Actively contributes to the evaluation of potential drug candidates for in-licensing.
• Contributes to the preparation, editing, and review of documents for regulatory submission (i.e., study reports, IB's, IND's).
• Independently and/or collaboratively conducts PK and PK/PD analyses during late-stage lead optimization through early pre-clinical development and collaborates in PK/PD and efficacy study design to support clinical dose setting.
• Provides strategic and hands-on leadership relating to PK and ADME issues for diverse modalities, including small molecules, biologics, and oligonucleotides.
• Develops and mentors junior DMPK team members.

Scope:

• In the PDT Nonclinical and Translational Sciences Team (NTS), the Bioanalytical & Biomarker Discovery Lead is responsible for driving the development of bioanalytical and biomarker assays using innovative technologies to support various programs in early (preclinical) and late (clinical) stages of development. The employee works closely with other members of the NTS team and Pharmaceutical Sciences team to develop translatable biomarker strategies for patient stratification and responder population analysis.

Key Accountabilities:

• Responsible for researching, designing, and managing the development of bioanalytical and biomarker methods, method validation, sample testing, as well as data interpretation and reporting.
• Applies independent judgment and direction to design, execute, and interpret experiments in compliance with appropriate global regulatory guidance.
• Manages and leads bioanalytical projects for programs across the portfolio and schedules activities in accordance with line function and program/corporate goals/assignments and priorities supporting discovery, non-clinical, and clinical programs.
• Authors or contributes to Biomarker Plans and Immunogenicity Risk Assessments.
• Effectively manages both internal and external work, including interactions with technical and administrative staff at CROs or external vendors to deliver high-quality results in a fast-paced environment.
• Reviews assay validation and bioanalytical reports and provides training and mentorship to internal staff.
• Implements innovative bioanalytical approaches and proposes biomarker strategies.
• Develops new methods and extends technology to drive applied science into new application areas.
• Represents the bioanalytical function in cross-functional program teams.
• Interacts with bioanalytical teams and experts across Takeda to harmonize approaches between PDT BU and Global Takeda R&D.
• Acts as a resource or provides guidance to colleagues.
• Authors or contributes to Clinical Study Report sections, regulatory documents, sample management plans, and abstracts/manuscripts for publication.
• Fosters the Takeda culture of Diversity, Equity, and Inclusiveness.

Dimensions and Aspects:

• Creativity, courageousness, collaborative, and empowerment.
• The NTS team cooperates with partners globally, therefore, the ability to define a cohesive culture based on Takeda's values is critical.
• Travel expectancy 10%.

Leadership:

• Ability to identify potential challenges and opportunities and make recommendations.
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company.
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization.
• Invests in helping others learn and succeed.
• Able to influence without authority at senior (TET-2/TET-3) level.

Decision-making and Autonomy:

• Accountable for acting decisively and exercising sound judgment in making decisions.
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence.
• Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities.
• Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution.
• Develops executable plans and meets budget and deadlines.
• Builds a culture of data-driven decisions.

Interaction:

• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions.
• Skilled communicator, able to persuasively convey ideas verbally and in writing.

Innovation:

• Disruptive thinker with the ability to influence and change how PDT uses data to make decisions and sets priorities.
• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Complexity:

• Recommends key decisions and escalates key issues per agreed governance framework.
• Creates clarity of accountabilities in a global and highly matrixed organization.
• Ability to provide data that will resolve or simplify complexity.
• Resilient and comfortable working through large-scale global change management.

Education and Experience Requirements:

• Academic degree MSc or above, preferably PhD with postdoc experience.
• 5+ years of industry/CRO experience in the area of biomarker and bioanalytical development.
• Familiarity and experience with global regulatory guidelines, expectations, and corresponding industry best practices is required, e.g., FDA Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP).
• Experience in managing external work at CROs/CMOs is required.
• Experience in large molecule assessments for PK, toxicology, and biodistribution studies as well as ADA and biomarker studies in various matrices and tissues to support both preclinical and clinical studies is of advantage.
• Comfortable with working in a fast-paced environment and comfortable with ambiguity.
• Shows examples of leadership and collaboration with multi-disciplinary cross-functional global development and strategy teams.
• Experience in molecular understanding of clinical manifestations, therapeutic approaches, and current research paradigms in focused areas of rheumatology, clinical immunology, hematology, gastrointestinal disorders, or hepatic diseases is desired.
• Recognized for having advanced expertise in their field of training and broad knowledge of drug discovery and development.
• Experience in translational research in industry is of an advantage.
• Successful track record of developing employees and team members is advantageous.