Primary Duties: * Reporting to Senior Director, Head of Bioanalytical and Biomarker group, the incumbent is responsible for leading a group of 3 highly experienced scientists to research, design, develop, validate and implement a broad range of bioanalytical and biomarker assays to support Research, Non-clinical, Clinical and Commercial programs for rare diseases in a variety of therapeutic indications. * Recognized as having advanced expertise in their field of training and broad knowledge of development; applies independent judgment and direction to design, execution, and interpretation of experiments in compliance with appropriate global regulatory guidance. * Effectively manage both internal and external work, including interactions with technical and administrative staff at CROs or external vendors to deliver high quality results in a fast-paced environment. * Implement innovative approaches and proposes new strategies within Research; develops new methods and extends technology to drive applied science into new application areas. * Effectively communicate and interface with internal/external business partners, including internal Compliance and Quality Assurance Units and Regulatory functions to ensure bioanalytical methods, validations and supporting reports are in compliance with applicable GLP, GCP and CLIA and other regulatory requirements. Manage and control of documents/records for compliant operations. * Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publication. Review assay validation and bioanalytical reports and provide training and mentorship to internal staff. Responsibilities: 50% Supervise a group of three highly competent scientists to Research, identify, design and implement high complexity bioanalytical test methods and/or biomarker strategies. 15% Manage external vendors/CROs and assess progress relative to objectives and communicates progress periodically to supervisor and key stakeholders within and outside Group. 10% Schedule technical work and performs high-level review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards 10% Review assay validation, bioanalytical/biomarker or immunogenicity protocols, reports. 10% Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publication. Review assay validation and bioanalytical reports and provide training and mentorship to internal staff. 5% Conducts performance appraisals, and makes recommendation on compensation and human resources issues.
Education and Experience Requirements: * PhD in life science (preferentially in immunology and/or physiology) with 5+ years of research experience in top ranking academic institutions and 12+ years of industry experience. * Experience in leading biological molecule PK and biodistribution as well as ADA, biomarker studies in various matrices (serum, CSF, urine) and tissues (brain, spinal cord, liver, kidney, spleen, lymph nodes) to support both non-clinical and clinical studies. * Familiarity and experience with global regulatory guidelines, expectations and corresponding industry best practices is required, e.g., FDA Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP). * Experience placing and managing external work at CROs/CMOs is required. * Experience in people management is required Key Skills, Abilities, and Competencies: * Significant experience in a regulated environment (pharmaceutical/biotech industry and/or CRO), in the design, development, validation, documentation and administration of bioanalytical and biomarker assays for large and small molecules is required. * Expertise in immunogenicity assessment and developing appropriate immunogenicity testing mitigation strategies to support drug development is required * Expertise on immunology especially B cell biology and regulation of immune response is highly preferred * Excellent management and organizational skills, and attention to detail, are essential. * Excellent written and oral communication skills are required. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.