Associate Scientific Director, Pharmacometrics

🕒 vor 2 Monaten

🇺🇸 Vereinigte Staaten – Remote

💵 $167.000 - $230.000 / Jahr

⏰ Vollzeit

🔴 Experte

👔 Direktor

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Biogen

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5001 - 10000 Mitarbeiter

🧬 Biotechnologie

⚕️ Krankenversicherung

💊 Pharmazie

Biotechnology • Healthcare Insurance • Pharmaceuticals

Biogen ist ein Biotechnologieunternehmen, das sich der Entdeckung, Entwicklung und Bereitstellung innovativer Therapien für Menschen mit schweren neurologischen Erkrankungen widmet, einschließlich Alzheimer, Multiple Sklerose und spinale Muskelatrophie. Mit einem starken Fokus auf Forschung und Entwicklung treibt Biogen die Wissenschaft der Neurologie durch klinische Studien und strategische Partnerschaften voran und strebt dabei gleichzeitig nach Zugang und gesundheitlicher Chancengleichheit im Gesundheitswesen.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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