Associate Director, Medical Affairs
Gilead Sciences
Associate Director, Pharmacometrics
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $152,600 - $283,400 per year
Job Level
Senior
About the role
- Provide global strategic pharmacometrics leadership for clinical development programs of medium to high complexity, based on relevant technical and disease area knowledge
- Develop, write, and execute pharmacometrics analysis plans, and deliver reports on results
- Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies
- Lead and optimize the provision of pharmacometric contributions to regulatory/submission strategy and related documents
- Represent the Global Project Teams internally and externally
- Drive and coordinate the synthesis and integration of pharmacometrics information to support transition of drug development milestones / decision boards
- Identify alternative strategic options to mitigate risk on clinical programs
- Lead and contribute to Integrated Evidence generation by leveraging disease progression and PKPD modeling techniques using varied data sources, including Real World Data
- Ensure that the Analytics team are aligned on the pharmacometrics strategy, execution, and delivery of assigned projects
- Represent PMX in due-diligence teams to evaluate in-licensing opportunities
Requirements
- Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent)
- 6+ years’ experience in clinical drug development applying model-based methods using NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation in academia and/or industry
- Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas
- Diverse experience in pharma industry on incorporation of MIDD strategies into drug development plans across all phases
- Track record of contributions to external whitepapers/ policy shaping best practice in pharmacometrics
- Internally and externally established track record of developing/establishing pharmacometrics excellence
Benefits
- health, life and disability benefits
- a 401(k) with company contribution and match
- generous time off package including vacation, personal days, holidays and other leaves
- performance-based cash incentive
- eligibility to be considered for annual equity awards
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacometricsmodel-based methodsNLME methodsDose-exposure-response analysispopulation PK/PD modelingdisease progression modelingclinical trial simulationquantitative development programsReal World DataIntegrated Evidence generation
Soft skills
leadershipstrategic thinkingcommunicationcollaborationrisk mitigationproject managementanalytical thinkingproblem-solvingcoordinationrepresentation
Certifications
Ph.D. in pharmacologyPh.D. in biologyPh.D. in engineeringPh.D. in mathematicsPh.D. in statistics
