Associate Scientific Director

🕒 vor 3 Monaten

🇺🇸 Vereinigte Staaten – Remote

💵 $144.000 - $240.000 / 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 clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development) • Provide functional representation on development programs and study teams and identify opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety • Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical) • Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies • Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results • Conduct hands-on quantitative analysis and present the findings to multidisciplinary project teams • Serve as lead author and key contributor to clinical pharmacology sections of documents • Serve as the subject matter expert in interactions with Health Authorities • Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed • Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes • Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent

🎯 Anforderungen

• PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields • 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD) • Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles • Experience with designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies • Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm • Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data • Hands-on experience with developing and implementing Quantitative Systems Pharmacology (QSP) models, and/or population PK, PKPD, exposure-response analyses • Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM • Excellent oral and written communication skills for effective interactions in various environments including multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards

🏖️ Vorteile

• medical, dental, life, long and short-term disability insurances • vacation • end-of-year shutdown • 401K participation and matching contributions • Fitness & Wellness programs including a fitness reimbursement • 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 • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year