About This RoleAs 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. This position is located in South San Francisco office or could be fully Remote. The candidate must reside within the USA.
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
- 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
- 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
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Additional Information The base compensation range for this role is $144,000.00-$240,000.00. Base salary is determined by a combination of factors including, but not limited to, job-related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
Job Level: Management
Additional InformationThe 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 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
