Associate Scientific Director/Scientific Director of Quantitative Clinical Pharmacology
Company: Takeda
Location: Somerville
Posted on: January 4, 2021
|
|
Job Description:
By clicking the ---Apply--- button, I understand that my
employment application process with Takeda will commence and that I
agree with Takeda---s Privacy Notice, Privacy Policy and Terms of
Use.Job DescriptionAre you looking for a patient-focused company
that will inspire you and support your career? If so, be empowered
to take charge of your future at Takeda. Join us as an Associate
Scientific Director/Scientific Director of Quantitative Clinical
Pharmacology in our Cambridge office. Here, everyone matters and
you will be a vital contributor to our inspiring, bold mission. As
an Associate Scientific Director/Scientific Director of
Quantitative Clinical Pharmacology working on the team, you will be
empowered to manage strategic, scientific and operational aspects
of multiple drug development programs from the clinical
pharmacology perspective, and a typical day will include: POSITION
OBJECTIVES:The Associate Scientific Director/Scientific Director
manages strategic, scientific and operational aspects of multiple
drug development programs from the clinical pharmacology
perspective.Serves as the Global Clinical Pharmacology Lead for
assets across phases 1-4 of development. Works closely with
functional experts across the R&D organization, such QS,
Research, Biostatistics, Regulatory Affairs, DMPK, Pharm Sci, and
Clinical Science providing leadership and guidance in clinical
pharmacology activities.Assists in departmental management through
program reviews and collaborative decision-making.Supervises and
mentors junior staff providing professional and career
development.ACCOUNTABILITIES:Provides scientific and strategic
leadership as the Clinical Pharmacology Lead for multiple programs
on Global Program Teams and associated scientific and operational
sub-teams.Responsible for drafting and executing clinical
pharmacology plans, including integration of M&S, in
collaboration with key partner functions (e.g., QS and DMPK).
Ensures that M&S plans are fully integrated with the overall
clinical pharmacology plans to enable Model-Informed Drug
Development (MIDD).Works closely with colleagues in QS to ensure
strategic integration of advanced modeling and simulation
approaches (e.g., QSP, MBMA) across the development continuum to
inform internal decisions and external regulatory
interactions.Creates or assists in the preparation of protocol
synopses, oversees program execution including protocol conduct,
data analysis and reporting.Responsible for clinical pharmacology
summary documents (such as IB, CTA, CTD Module 2 documents, product
labeling).Oversee and/or independently perform PK/PD analyses
including the interpretation of PK/PD data and associated
statistical analyses in close partnership with external CRO
partners.Maintains a high standard for good clinical practice,
compliance and ethics.Mentors junior staff to ensure they value
scientific excellence.Represents Clinical Pharmacology in meetings
with global regulatory agencies for his/her assigned
programs.Participates as a member of Business Development due
diligence, when required.CORE ELEMENTS RELATED TO THIS ROLE This
role will be expected to be the primary point of accountability in
QCP at the asset level for assigned programs and will provide
scientific and strategic input as the Clinical Pharmacology Lead on
the respective Global Program Teams and associated scientific and
operational sub-teams.DIMENSIONS AND ASPECTS Technical/Functional
(Line) ExpertiseDemonstrated expertise in application of PK/PD,
modeling and simulation, and use of clinical biomarkers for
decision making.Demonstrated scientific and technical expertise
through publications, patents, awards/honors or credibility at
professional societies. Strong knowledge of allied fields critical
for drug development, such as drug metabolism, pharmacology,
toxicology, bioanalytical chemistry, and pharmaceutical
science.Demonstrated experience with design and analysis of
clinical pharmacology studies.LeadershipEffective at building
alliances across functions.Excellent interpersonal communication
skills, able to drive global collaborations in cross-functional,
multi-cultural organizations.Excellent oral and written
communication skills, including writing, reviewing and editing
scientific documents.Ability to effectively influence colleagues
and multi-disciplinary project teams.EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS:Associate Scientific Director Level: Ph.D
or Pharm D. w/ 10 years or M.S. w/ 12 years or B.S. w/ 15 years of
pharmacometrics, clinical pharmacology, pharmacokinetic, or other
relevant experience.Scientific Director Level: Ph.D w/ or Pharm D.
w/ 12 years or M.S. w/ 14 years or B.S. w/ 16 years of experience
in pharmacometrics, clinical pharmacology, pharmacokinetic, or
other relevant experience.WHAT TAKEDA CAN OFFER YOU:401(k) with
company match and Annual Retirement Contribution PlanTuition
reimbursementCompany match of charitable contributionsHealth &
Wellness programs including onsite flu shots and health
screeningsGenerous time off for vacation and the option to purchase
additional vacation daysCommunity Outreach ProgramsEmpowering Our
People to ShineLearn more at takedajobs.com.No Phone Calls or
Recruiters Please.LI-JV2LocationsCambridge, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeFull time
Keywords: Takeda, Somerville , Associate Scientific Director/Scientific Director of Quantitative Clinical Pharmacology, Executive , Somerville, Massachusetts
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Executive JobsOncology Account Manager- Boston North Description: Oncology is a core area of intensive focus at GSK, and while much progress has been made in the past few years, more can be done to REDEFINE EXPECTATIONS in cancer care. As we look to redefine expectations (more...) Company: GlaxoSmithKline Location: Boston Posted on: 01/16/2021 Senior Director, Hematology Clinical Development Sciences Description: This position will be based in Boston, MAPosition SummaryThe Senior Director, Hematology Clinical Sciences will provide medical input to Global Program Teams GPTs , serve as medical expert for the study (more...) Company: Alexion Pharmaceuticals Location: Boston Posted on: 01/16/2021 Facilities Manager Description: Family Practice-Without OB opening in Brighton, Massachusetts. This and other physician jobs brought to you by DocCafe.com We are seeking a Facility Manager to join our practice in Waltham/Brighton, MA. (more...) Company: Northeast Healthcare Recruitment, Inc. Location: Brighton Posted on: 01/16/2021 Implementation Manager (Remote) Description: About us:Grand Rounds is a tech-driven healthcare company dedicated to raising the standard of healthcare for everyone, everywhere. By harnessing the power of technology, we connect nearly 6 million members (more...) Company: Grand Rounds Location: Boston Posted on: 01/16/2021 Director of Product Data Platform Description: Job : 638815Release Date: 12/09/2020Company: Retail / Retail Stores, Boston, MASalary: ConfidentialRemarks:We are seeking a Director, Product - Company Health --- Data Platform in Digital and Technology (more...) Company: ExecuNet Location: Boston Posted on: 01/16/2021 Senior Safety Operations Manager Description: Working Location: MASSACHUSETTS, SOUTHBOROUGH PENNSYLVANIA, CENTER VALLEY Are you looking for a company that cares about people---s lives and health, including yours At Olympus, we help make people---s (more...) Company: Olympus Location: Southborough Posted on: 01/16/2021 Associate Director Medical Information & Oper Description: Albireo Pharma Overview: Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan pediatric liver (more...) Company: Albireo Pharma, Inc. Location: Boston Posted on: 01/16/2021 Domino's General Manager Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...) Company: Domino's Location: Saugus Posted on: 01/16/2021 Travel Nurse RN - Case Management - $1,578 per week Description: TotalMed RevTech Staffing is seeking a travel nurse RN Case Management for a travel nursing job in Boston, Massachusetts.Job Description Requirements ul li Specialty: Case Management li Discipline: (more...) Company: NurseFly Location: Boston Posted on: 01/16/2021 Implementation Project Manager Description: br br Kelmar Associates is looking for a highly motivated, detail-oriented, team-focused professional to join our team of Implementation Project Managers. An expert in all facets of the implementation (more...) Company: Kelmar Location: Wakefield Posted on: 01/16/2021 |