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Scientific Associate Director/Associate Director Bioanalytical Sciences Biologics, CBID

Company: Takeda
Location: Boston
Posted on: August 3, 2020

Job Description:

By clicking the Apply button, I understand that my employment applic process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use. Job_Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientific Associate Director/Associate Director Bioanalytical Sciences-Biologics, in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. As a Scientific Associate Director/Associate Director Bioanalytical Sciences- Biologics, working on the Clinical Biomarker Innovation & Development team, you will be empowered to play a critical role in Bioanalytical Sciences (BAS)- Biologics group and drive its pharmacokinetics and immunogenicity strategy design and implementation that will impact clinical development paradigms and bring value to patients. A typical day will include POSITION OBJECTIVES * The Clinical Biomarker Innovation & Development department at Takeda is seeking a strong scientific and strategic leader to join its Bioanalytical Sciences (BAS)-Biologics group and drive its pharmacokinetics and immunogenicity strategy design and implementation that will impact clinical development paradigms and bring value to patients. The candidate will manage projects in different therapeutic modalities across Oncology, Neuroscience, Gastroenterology, Immuno- oncology, and Rare Diseases. * Partner in developing a strong and compelling vision for the Bioanalytical Sciences organization, which ensures meeting critical needs of the company, and its development and commercial pipeline. With an increase in the therapeutic areas, complexity, diversity and number of molecules/modalities in our portfolio, we expect the leader to provide technical, drug development and regulatory expertise in all aspects of bioanalytical sciences-with emphasize on pharmacokinetics and immunogenicity on different therapeutic modalities including antibodies, ADC, recombinant human proteins/enzymes, multidomain fusion proteins, cell & gene therapies. An additional requirement is the ability to develop and leverage cutting-edge technologies that can significantly impact clinical drug development decisions and bring value to patients and prescribers. * Encouraged to establish their own laboratory, train post-docs, junior scientists and interns. * Coach to the group. 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. POSITION ACCOUNTABILITIES * SME for immunogenicity assessment, risk mitigation strategies, developing collaborations with health authorities to understand these issues. * Represent BAS and CBID at internal scientific reviews and governance. meetings, external forums and consortia and any health authority interactions. * Drive, develop and oversee execution of bioanalytical strategy and plans within the BAS group and Takeda designated CROs. Accountable for group s delivery of clinical bioanalytical results and reports, and regulatory requirements for assay development, validation and clinical studies. * Provide bioanalytical scientific leadership to enable and drive robust and timely-decision making through all stages of clinical development at program team meetings and during regulatory interactions. * Build relationships & collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities * Lead scientific due diligence to assess cutting-edge technologies and establish external partnerships as needed. * Oversee plans for technical on-site visits of external laboratories responsible for testing clinical bioanalytical samples. * Coach and guide staff 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. * Accountable for the achievement of critical goals that impact and contribute to the mission of CBID and Takeda Education,_Behavioral_Competencies_And_Skills * A PhD or MD/PhD in pharmacology, immunology or related discipline with at least 10 years of experience in the industry * A track record of sustained, significant scientific contributions as demonstrated by publications, patents and presentations * Extensive drug development experience from phase I to approval and supporting post-marketing/commercial activities. * Strong scientific background and experience with clinical bioanalytical assay development and validation. Subject matter expert in PK and immunogenicity assay strategy design and implements, experiences in cell and gene therapy is plus. * Capable of applying the highest scientific and technical standards for the successful design and execution of clinical bioanalytical assays implemented from early to late-stage clinical programs. * Strong communication skills; experienced in navigating large, highly complex, global matrixed environments. * Broad and strong network in the industry, biotech, and health authorities. What_Takeda_Can_Offer_You * 401(k) with company match and Annual Retirement Contribution Plan * Tuition reimbursement Company match of charitable contributions * 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 Empowering Our People to Shine Discover more at No Phone Calls or Recruiters Please. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Show moreShow less

Keywords: Takeda, Boston , Scientific Associate Director/Associate Director Bioanalytical Sciences Biologics, CBID, Executive , Boston, Massachusetts

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