Associate Scientific Director / Principal Scientist Bioanalytical Sciences-Biologics, CBID
Company: Takeda
Location: Boston
Posted on: January 27, 2023
Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAssociate Scientific
Director / Principal Scientist Bioanalytical Sciences-Biologics,
CBID Are you looking for a patient-focused, innovation-driven
company that will inspire you and empower you to shine? Join us as
Associate Scientific Director / Principal Scientist Bioanalytical
Sciences-Biologics, CBID 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 Associate Scientific
Director / Principal Scientist Bioanalytical Sciences-Biologics,
CBID working on the Clinical Biomarker Innovation and Development
team, you will be empowered to 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. Manage projects in different therapeutic
modalities across 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,
- 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.
- Develop and leverage cutting-edge technologies that can
significantly impact clinical drug development decisions and bring
value to patients and prescribers.
- Establish their own laboratory, train post-docs, junior
scientists and interns.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
peopleEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- A PhD or MD/PhD in pharmacology, immunology or related
discipline with at least 10 year experiences in the industry
- A track record of sustained, significant scientific
contributions as demonstrated by publications, patents and
presentations
- Extensive drug development experience preferably advancing
several molecules from phase I-4 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; ability to influence and inspire,
preferably experienced in navigating and influencing large, highly
complex, global matrixed environments.
- Broad and strong network in the industry, biotech, and health
authoritiesTakeda U.S. Vaccine Requirement:Absent an approved
religious or medical reason, all US office-based and lab-based
Takeda employees who work fully on-site or in a hybrid model (as
determined by Takeda) must be fully vaccinated to work at a Takeda
site or to engage with Takeda colleagues or anyone else on behalf
of Takeda. As of the same date, absent an approved religious or
medical reason, US field-based employees, employees must be fully
vaccinated in order to continue in their current roles. US
employees who work at a Takeda manufacturing facility, and those
who work at a BioLife center or BioLife lab, may be subject to
different guidelines. Candidates are encouraged to speak with their
recruiter to seek further information on the applicable guidelines
for the Business Unit/Function for which they have applied.This job
posting exclude Colorado applicants.TRAVEL REQUIREMENTS:
- Some domestic and international travel to Takeda sites,
bioanalysis vendors, and regulatory agencies may be required.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 ProgramsEmpowering Our People to
ShineDiscover more at No Phone Calls or Recruiters Please. RM-LIEEO
Statement Takeda is proud in its commitment to creating a diverse
workforce and providing equal employment opportunities to all
employees and applicants for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, gender
expression, parental status, national origin, age, disability,
citizenship status, genetic information or characteristics, marital
status, status as a Vietnam era veteran, special disabled veteran,
or other protected veteran in accordance with applicable federal,
state and local laws, and any other characteristic protected by
law. LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda, Boston , Associate Scientific Director / Principal Scientist Bioanalytical Sciences-Biologics, CBID, Executive , Boston, Massachusetts
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