Associate Scientific Director, Clinical Pharmacology

About This Role

Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. As the Lead, Clinical Pharmacology, Immunology, you will serve on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. You will integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for dosage regimens, and study designs throughout the drug development lifecycle.

What You'll Do

• 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

Qualifications

• 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
• 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
• Experience with Model Informed Drug Development (MIDD) paired meeting program is a plus
• Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM. Experience with Monolix and MATLAB is a plus
• 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

Additional Information

The base compensation range for this role is: $144,000.00-$240,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In Addition To Compensation, Biogen Offers a Full And Highly Competitive Range Of Benefits Designed To Support Our Employees’ And Their Families physical, Financial, Emotional, And social Well-being; Including, But Not Limited To: Medical, Dental, Vision, & Life insurancesFitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insuranceA 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 yearPaid Maternity and Parental Leave benefit 401(k) program participation with company matched contributionsEmployee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation