Associate Scientific Director – Clinical Pharmacology

🕒 March 4

🇺🇸 United States – Remote

💵 $144k - $240k / year

⏰ Full Time

🔴 Lead

👔 Director

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

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 clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development) • Provide functional representation on development program and study teams • 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 • Serve as lead author and key contributor to clinical pharmacology sections of clinical and regulatory documents • 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.

🎯 Requirements

• 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 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 • Experience with use of PK/PD software packages such as Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SAS • Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards.

🏖️ 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