Senior Director, Drug Metabolism Pharmacokinetics & Modeling
Company: Takeda Pharmaceutical
Location: Boston
Posted on: November 12, 2024
Job Description:
By clicking the "Apply" button, I understand that my employment
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with Takeda's Privacy Notice and Terms of Use. I further attest
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAt 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.Objective / Purpose: - -
- Represents GI2 (Inflammation & Immunology) DDU, TAU andGI2
project portfolio as an engaged member of the DMPK&M Leadership
Team. -
- Regularly and actively participates in appropriate DMPK LT
meetings to give briefing updates on therapeutic area status,
critical issues, and major milestones. -
- In partnership with DMPK&M lead is responsible for DMPK
strategy and its execution for all GI2 DDU and TAU projects. -
- Runs and maintains regular operational/strategy meetings of all
DMPK staff involved in supporting GI2 portfolio. -
- Is ultimately accountable for study protocol reviews to support
DMPK Project Team Representatives in experimental design and data
interpretation. -
- Reviews study reports and regulatory documents for scientific
accuracy and consistency of human risk assessment message -
- Provides continuous mentorship and performance feedback to DMPK
Project Team Representatives -
- Frequently interacts with the Global Head, DMPK partnership
leads, fellow DMPK&M SPOCs and/or Heads of DMPK&M
Sub-Discipline Functions to address questions on strategy and to
anticipate and resolve potential issues. - -Accountabilities: - - -
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
- - - - -
- Provides strategic leadership across GI2 (Inflammation &
Immunology) DDU and TAU representing DMPK. Makes strategic
decisions in consultation with senior leaders to advance research
projects from target selection to clinical submission. -
- Provides scientific leadership to ensure selection of clinical
candidates with optimal drug development characteristics and
appropriate characterization and development of these candidates. -
-
- Provides scientific and strategic guidance on stage-appropriate
questions related to drug metabolism, bioanalysis, quantitative
biomarkers, PK, and PK/PD. -
- Guides efficient design and execution of studies in support of
drug candidates. -
- Oversees GI2 project portfolio as the DMPK Leadership Team
nominee, ensuring that the DMPK strategy is in alignment with other
functions in discovery and development. -
- Interacts directly with DDU and TAU head (or designee) to
determine goals, strategy, and execution of the development of drug
candidates. -
- Is actively participating in the DDU and TAU leadership
discussions and decision-making. - -
- Provides scientific and strategic expertise to DMPK Project
Team Representatives for the development of TA drug candidates.
-
- Reviews and advises on data, reports, scientific conclusions,
and presentations -
- Approves DMPK components of drug strategy for all GI2 projects
at appropriate milestones, reviews and approves the appropriate
sections of internal project documentation. -
- Is well-informed on the latest trends in the competitive and
regulatory landscape, particularly as it relates to specific
therapeutic area. -
- Aligns goals and resources with DDU and TAU, and communicates
those needs to DMPK Head, and other DMPK functional leaders, as
needed. -
- Consults with Head of ADME, Bioanalytical, Biomarker,
Translational Partners, and New Modality Support Teams and line
function Heads to ensure that appropriate personnel from their
lines are assigned to projects at the appropriate time -
- Reviews and approves regulatory documents and correspondence on
behalf of DMPK - -Education & Competencies -
- PhD with 15+ years' industry experience or equivalent (MS with
21+ years' experience, or BS with 23+ years' experience) -
- Good understanding of the GI2 (Inflammation & Immunology
DDU/TAU project portfolio, disease indications, and typical DMPK
considerations for patients - -
- Experience of working with multiple modalities ideally small
molecules, ASOs, gene therapy, cell therapy and biologics -
- Experience in all stages of drug development from discovery to
marketed product support -
- Experience in making recommendations to senior management of
other line functions regarding key program decisions. - -
- Experience in regulatory submission (INDs, CTA, NDAs, MAAs) and
in health authority (FDA, EMA, PMDA) interactions, and experience
in developing strategies around those interfaces in collaboration
with the Regulatory function - -This position is currently
classified as "hybrid" by Takeda's Hybrid and Remote Work
policy.Takeda Compensation and Benefits SummaryWe understand
compensation is an important factor as you consider the next step
in your career. We are committed to equitable pay for all
employees, and we strive to be more transparent with our pay
practices. -For Location:Boston, MAU.S. Base Salary
Range:205,100.00 - 322,300.00The estimated salary range reflects an
anticipated range for this position. The actual base salary offered
may depend on a variety of factors, including the qualifications of
the individual applicant for the position, years of relevant
experience, specific and unique skills, level of education
attained, certifications or other professional licenses held, and
the location in which the applicant lives and/or from which they
will be performing the job.---The actual base salary offered will
be in accordance with state or local minimum wage requirements for
the job location. -U.S. based employees may be eligible for
short-term and/ or long-term incentives. U.S. based employees may
be eligible to participate in medical, dental, vision insurance, a
401(k) plan and company match, short-term and long-term disability
coverage, basic life insurance, a tuition reimbursement program,
paid volunteer time off, company holidays, and well-being benefits,
among others. U.S. based employees are also eligible to receive,
per calendar year, up to 80 hours of sick time, and new hires are
eligible to accrue up to 120 hours of paid vacation. -EEO
StatementTakeda 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 timeJob ExemptYes
Keywords: Takeda Pharmaceutical, Revere , Senior Director, Drug Metabolism Pharmacokinetics & Modeling, Executive , Boston, Massachusetts
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