Associate Director, Global Medical Affairs
EVERSANA
Senior Director, Quantitative Clinical Pharmacology Lead
Takeda
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $208,200 - $327,140 per year
Job Level
Senior
About the role
- Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management.
- Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.
- Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data and Quantitative Sciences (DQS) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.
- Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DQS and external partners.
Requirements
- Pharm D. or PhD with 12+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD
- MS with 15+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD
- Established Subject Matter Expert in multiple areas internally or externally including leadership of one or more internal or external focus groups.
- Expert knowledge and/or hands-on applications; integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and quantitative decision making.
- Extensive experience in global filings and approvals or interactions with global regulatory experience for development strategy and submission plan.
Benefits
- U.S. based employees may be eligible for short- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
PK analysisPD analysispharmacometric analysisdata integrationquantitative decision makingclinical pharmacologydose selectionglobal filingsregulatory experiencesubmission planning
Soft skills
leadershipcollaborative decision-makingstrategic independencecommunicationambassadorshipscientific participationpublication impact
Certifications
Pharm DPhDMS
