Bioanalytical & Biomarker Sciences Lead

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.

Plasma-derived therapies are critical, life-saving medicines, which patients with rare and complex diseases around the world rely on every day.

Global demand for these therapies, particularly immunoglobulins, has increased dramatically over the last 15 years, and continues to grow.

Takeda is established as second largest provider of producing plasma-derived therapies (PDT) globally. Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet expectations of patients and health care providers with plasma-derived therapies for patients with immunologic, hematologic, autoimmune and other complex diseases.

Within 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 nonclinical- and clinical-stage programs.

How you will contribute :

ACCOUNTABILITIES

• Establishes project direction through integrating science, key technical knowledge, and program objectives
• Provides leadership to enable project teams to make informative 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 / 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 PDT Nonclinical and Translational Sciences Team (NTS), the Bioanalytical & Biomarker Discovery Lead is responsible for driving 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 NTS team and Pharmaceutical Sciences team to develop translatable biomarker strategies for patient stratification and responder population analysis.

In addition, the employee also works closely with various key stakeholder functions (eg. Clinical Science, Clinical Operations, Medical Writing) and represents Bioanalytical function in various global program teams and sub-teams.

ACCOUNTABILITIES

• Responsible for researching / designing and managing 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 portfolio and schedules activities in accordance with line function and program / corporate goals / assignments and priorities supporting discovery, nonclinical 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 provide 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 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, 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 exercise 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 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.
3 days ago