Associate Scientific Director, Pharmacometrics

🕒 March 23

🇺🇸 United States – Remote

💵 $167k - $230k / year

⏰ Full Time

🔴 Lead

👔 Director

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Provide pharmacometrics expertise to activities throughout the drug development lifecycle and effectively collaborate with cross functional teams • Execute advanced pharmacometrics analyses, with emphasis on PK/PD modeling and simulation and exposure-response analysis for high priority programs • Identify opportunities where modeling and simulation can advance the understanding of pharmacokinetics, pharmacodynamics, efficacy and safety • Contribute to Model Informed Drug Development (MIDD) activities to support dose selection, regimen optimization and clinical trial design • Communicate the pharmacometrics analysis results to program teams to support data-driven decision-making process • Mentor and guide Clinical Pharmacology and Pharmacometrics colleagues on pharmacometrics analyses methodologies • Serve as a lead author and key contributor for pharmacometrics sections of clinical and regulatory documents • Publish in scientific journals and present at internal and external scientific events

🎯 Requirements

• PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or a related quantitative discipline. • 5+ years of relevant industry experience applying population PK/PD and other advanced quantitative methodologies to decision making • Deep and extensive experience with advanced population PK/PD methodology • Strong understanding of the clinical pharmacology principles and methodologies and their application in drug development • Solid knowledge of the drug development process and regulatory expectations for pharmacometrics analyses • Ability to interpret quantitative results and translate analyses into actionable program insights • Hands-on experience with pharmacometrics software tools such as NONMEM, Monolix, and R. • Experience with mechanistic or systems pharmacology models is a plus.

🏖️ Benefits

• Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation