Director, Clinical Pharmacology Position Available In Suffolk, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employmentapplication process with Takeda will commence and that theinformation I provide in my application will be processed in linewith Takeda’s Privacy Notice and Terms of Use . I further attestthat all information I submit in my employment application is trueto the best of my knowledge. Job Description Director, ClinicalPharmacology Cambridge, MA Hybrid Job Posting Description The

PDTBU R D

group is dedicated to bringing forward new therapeuticapproaches based on plasma-derived therapies for patients with rareand complex diseases. Takeda believes there is tremendous potentialto do more to meet patients’ and health care providers’expectations with plasma-derived and plasma-oriented therapies forpatients with immunologic, hematologic, and other complex diseases.

This individual will work in a highly matrixed team setting andensures close collaboration with other PDT BU functions andrelevant Takeda R D functions to support project goals. Thisindividual will contribute to the clinical pharmacology andpharmacometrics strategy to support PDT project progression fromentry to clinical development to life cycle management Thisindividual will act as the global clinical pharmacology lead on PDTprojects and contribute to regulatory submissions and interactions.

This role requires a strong strategic thinking, excellent verbaland written communication skills, and in-depth ClinicalPharmacology and PK/PD knowledge.

ACCOUNTABILITIES

Design clinicalpharmacology programs to support the development, registration andcommercialization of Takeda’s plasma derived products. RepresentClinical Pharmacology on different product development teams.

Provides input into all phases of drug development including, butnot limited to dose finding, dose optimization, exposure-response,and pediatric development. Leads study design, execution andreporting of clinical pharmacology studies Identify, design,conduct and/or oversee pharmacometrics projects to support theprogram progression and regulatory submissions. The relevantpharmacometrics projects may include and are not limited to:non-compartmental

PK, PK/PD

analyses, population PK and PK/PD, andother modeling and simulation activities as appropriate for theproject. Contribute to regulatory documents including InvestigatorBrochures, Labeling and those required for regulatory strategies,interactions and regulatory filings. Provides resolution ofclinical pharmacology queries from regulatory agencies, taking alead role in writing and reviewing responses to regulatory queries.

Write/Review Clinical Pharmacology Plans and Reports, as well asrelevant sections of CSRs. Manage outsourcing activities andapproved budget accordingly. Manage contract requisition, SOW andapproval of invoices. May participate in identification andevaluation of potential business development opportunities in PDTR D, conducts due diligence evaluations.

EDUCATION, BEHAVIOURALCOMPETENCIES AND SKILLS

A Ph.D., Pharm D, MD or equivalent degreewith at least 10 years of clinical pharmacology experience withinthe pharmaceutical industry. Educational background in clinicalPharmacology, biopharmaceutics, pharmaceutical sciences, biomedicalengineering, or a related field. Skills Demonstrated ability tosuccessfully manage the clinical pharmacology/pharmacokineticcomponents of multiple drug products across all phases ofdevelopment Demonstrated ability to successfully manage clinicalpharmacology and pharmacokinetic aspects of regulatory agencyinteractions and label negotiations Ability to work independently,take initiative and complete tasks to deadlines Ability toproactively identify issues and solve problems. Requires strongattention to detail in composing and proofing materials,establishing priorities, scheduling and meeting deadlines Provenability to work effectively in a matrixed environment Ability toeffectively present information to management at all levels of theorganization Demonstrated ability to set goals and objectives,establish and recalibrate priorities, provide feedback and appraisework. Strong judgment and decision-making skills with the abilityto understand how decisions fit into the broader context of PDTR D strategies. Diplomacy and positive influencing abilitiesExcellent interpersonal, verbal and written communication,analytical, and organizational skills Demonstrated ability tosuccessfully manage external consultants/vendors Knowledge Deepunderstanding and direct hands-on experience with pharmacometrics,PK/PD and statistical analysis using NonMEM, Phoenix NLME and otherrelevant data analysis tools. Excellent working knowledge of phaseI clinical operations, drug development, multi-region regulatoryrequirements and PK/PD analysis. Knowledge of the latestdevelopments in clinical pharmacology, pharmacometrics andregulatory guidance documents. Sound knowledge of drug regulatoryauthority biopharmaceutics and clinical pharmacology requirementsto support the clinical development and marketing of new drugproducts Sound knowledge of GCP regulations and familiarity withGLP and GMP requirements Sound knowledge of the drug developmentprocess, and a detailed understanding of non-clinical and clinicalDMPK processes Sound working knowledge of the cross-functionalinterfaces that are important for efficient drug developmentExperience in plasma derived/related therapies highly desired

WHATTAKEDA CAN OFFER YOU

• 401(k) with company match and AnnualRetirement Contribution Plan
• Tuition reimbursement Company matchof charitable contributions
• Health & Wellness programs includingonsite flu shots and health screenings
• Generous time off forvacation and the option to purchase additional vacation days
• Community Outreach Programs Empowering Our People to Shine Discovermore at takedajobs.

com No Phone Calls or Recruiters Please. Thisjob posting exclude Colorado applicants. LI-Hybrid TakedaCompensation and Benefits Summary We understand compensation is animportant factor as you consider the next step in your career. Weare committed to equitable pay for all employees, and we strive tobe more transparent with our pay practices.

For Location:

Boston,MA U.S.

Base Salary Range:

$169,400.00 – $266,200.00 The estimatedsalary range reflects an anticipated range for this position. Theactual base salary offered may depend on a variety of factors,including the qualifications of the individual applicant for theposition, years of relevant experience, specific and unique skills,level of education attained, certifications or other professionallicenses held, and the location in which the applicant lives and/orfrom which they will be performing the job.

The actual base salaryoffered will be in accordance with state or local minimum wagerequirements for the job location. U.S. based employees may beeligible for short-term and/or long-termincentives. U.S.basedemployees may be eligible to participate in medical, dental, visioninsurance, a 401(k) plan and company match, short-term andlong-term disability coverage, basic life insurance, a tuitionreimbursement program, paid volunteer time off, company holidays,and well-being benefits, among others. U.S.based employees are alsoeligible to receive, per calendar year, up to 80 hours of sicktime, and new hires are eligible to accrue up to 120 hours of paidvacation. EEO Statement Takeda is proud in its commitment tocreating a diverse workforce and providing equal employmentopportunities to all employees and applicants for employmentwithout regard to race, color, religion, sex, sexual orientation,gender identity, gender expression, parental status, nationalorigin, age, disability, citizenship status, genetic information orcharacteristics, marital status, status as a Vietnam era veteran,special disabled veteran, or other protected veteran in accordancewith applicable federal, state and local laws, and any othercharacteristic protected by law. Locations Boston, MA Worker TypeEmployee Worker Sub-Type Regular Time Type Full time Job Exempt YesIt is unlawful in Massachusetts to require or administer a liedetector test as a condition of employment or continued employment.

An employer who violates this law shall be subject to criminalpenalties and civil liability.