Associate Director Bio-analytical Sciences
Posted on Apr 5, 2021 by Takeda Pharmaceuticals
The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients' and health care providers expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. This is a new R&D organization, and the incoming leader will have the ability to create and define the future vision and operating model for the team.
The PDT R&D group is developing two innovation engines:
Translational Pharmaceutical Sciences: This innovation engine will practice rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield. This combines translational research with pharmaceutical sciences and device, and it receive inputs from and into clinical research and manufacturing sciences.
Precision Medicine: This engine will focus on developing comprehensive, value-oriented health care delivery packages around drug products, targeted to maximize benefit and reduce risk to precise patient populations. In the process, we expect that this engine will innovate the health care R&D paradigm by practicing patient-centric R&D.
As a responsible person for influencing Bioanalytical Sciences, the incumbent is responsible for guiding new, innovative ideas supporting various plasma derived therapies both in early and late stage assets. He/She will work closely with other members of the translational research and pharmaceutical sciences team to develop translatable biomarker strategy for patient stratification and responder population analysis. In addition, the incumbent will also work closely with various key stakeholder functions (eg. Clinical team) and represent translational research function in various global program teams and sub teams.
Responsible for researching/designing and managing a broad range of bioanalytical and biomarker method development, validation, sample testing, as well as data interpretation and reporting.
Recognized as having advanced expertise in their field of training and broad knowledge of drug discovery and development. Applies independent judgment and direction to design, execute and interpret experiments in compliance with appropriate global regulatory guidance.
Manage or lead projects for multiple programs across the portfolio and schedules activities in accordance with line function and program/corporate goals/assignments and priorities supporting Discovery, Nonclinical and Clinical programs. Author Immunogenicity Risk Assessments and Biomarker Plans.
Drive, develop, and oversee execution of bioanalytical strategy and plans supporting pre-clinical and clinical programs.
Implement innovative approaches and propose new strategies within the RD organization. Develops new methods and extends technology to drive applied science into new application areas.
Provide bioanalytical representation on multiple cross-functional program teams. Act as a resource or provide guidance to colleagues. Coach and guide internal stakeholders on scientific concepts and technical details of various bioanalytical methodologies. Play a major role in developing and maintaining a culture that is innovative, encourages risk, and supports the development of its people.
Author or contribute to Clinical Study Report sections, regulatory documents, and abstracts/manuscripts for publication. Review assay validation and bioanalytical reports and provide training and mentorship to internal staff.
Education & Experience Requirements:
PhD in life science with more than 8+ years of industry experience.
Experience in large molecule assessments for PK, toxicology and biodistribution studies as well as ADA and biomarker studies in various matrices and tissues (brain, spinal cord, liver, kidney, spleen, lymph nodes) to support both non-clinical and clinical studies.
Familiarity and experience with global regulatory guidelines, expectations and corresponding industry best practices is required, eg, FDA Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP).
Superior executive communication skills; ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments with and without authority
Build relationships & collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities.
Broad and strong network in the industry, biotech, CRO communities, and health authorities.
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.