Director, Access Strategy – Dupixent, Rhinology, Allergy, Gastroenterology
Sanofi
Pharmacometrician Director
Ipsen
full-time
Posted on:
Location Type: Office
Location: Cambridge • 🇺🇸 United States
Visit company websiteSalary
💰 $177,000 - $259,600 per year
Job Level
Lead
About the role
- Define and implement Pharmacometrics strategies
- Lead the development and execution of Pharmacometrics (PMx) plans for New Chemical Entities (NCEs) and New Biological Entities (NBEs) to support regulatory submissions.
- Drive the PMx strategy across non-clinical and clinical projects, contributing to modeling and simulation activities to guide drug development decisions.
- Identify opportunities to leverage Model-Informed Drug Development (MIDD) to optimize study designs and enhance program success.
- Inform drug development strategies to support decision-making and successful approvals.
- Ensure the timely delivery and high quality of PMx documents, including dataset specifications, analysis plans, and reports.
- Collaboratively author and review key documents where PMx is a contributor, such as clinical development plans, pediatric investigational plans, and submission packages.
- Represent the PMx group in project teams and cross-functional initiatives.
- Collaborate with teams across early development, pharmacology, biometry, and clinical operations.
- Conduct or oversee hands-on PMx activities and perform modeling and simulation activities, including population PK/PD, exposure–response, disease progression, and minimal PBPK modeling.
- Plan, budget, and manage subcontracted PMx activities, including PK/PD and PBPK studies.
Requirements
- 6+ years of experience in Pharmacometrics within the pharmaceutical industry, CROs, regulatory agencies, or academia.
- Proficiency in modeling and simulation (Population PK/PD, Translational PK/PD, tumor growth model, Time-to-event model, joint modeling, item-response theory).
- Experience with regulatory submissions (e.g., Module 2.7.2 - Clinical Pharmacology Overview, meeting with regulatory agencies).
- Strong expertise in at least one PMx software (NONMEM or MONOLIX).
- Proficiency in data management, plot generation, and statistical software (R).
- Strong analytical and problem-solving skills.
- Excellent scientific writing, interpersonal communication, and networking skills.
- Attention to detail in a time-sensitive environment.
- Familiarity with good clinical/laboratory practices (GxPs).
- Experience working with CROs.
Benefits
- 401(k) with company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Short- and long-term disability insurance
- Flexible spending accounts
- Parental leave
- Paid time off
- Discretionary winter shutdown
- Well-being allowance
- Commuter benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Pharmacometricsmodeling and simulationPopulation PK/PDTranslational PK/PDtumor growth modelTime-to-event modeljoint modelingitem-response theorydata managementstatistical analysis
Soft skills
analytical skillsproblem-solving skillsscientific writinginterpersonal communicationnetworking skillsattention to detailcollaborationleadershiporganizational skillstime management