Senior Director, Drug Metabolism Pharmacokinetics & Modeling
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 30, 2024
Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . 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 time
Keywords: Takeda Pharmaceutical, Brookline , Senior Director, Drug Metabolism Pharmacokinetics & Modeling, Executive , Boston, Massachusetts
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