Provide clinical pharmacology expertise to program and study teams throughout a molecule's lifecycle (discovery through development)
Provide functional representation on development program s and study teams and identify opportunities where modeling and simulation can ad vance 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 - o n quantitative ana lysis 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
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 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 . E xperience 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
Why Biogen?
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are foc
Benefits
Health insuranceDental insurance401(k)Paid time offRemote work optionsEquity / stock options
Additional Information
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. This position is located in South San Francisco office or could be fully Remote . T he candidate must reside within the USA.
Biogen · Remote