Bioanalytical & Biomarker Development Lead (Associate Director level)
Lexington , Massachusetts
April 03, 2017
Primary Role:
• Responsible for researching/designing and managing a broad range of bioanalytical and biomarker method development, validation, sample testing, as well as data interpretation and reporting.
• Recognized as having advanced expertise in their field of training and broad knowledge of drug discovery and development. Applies independent judgment and direction to design, execute and interpret experiments in compliance with appropriate global regulatory guidance.
• Manage or lead projects for multiple programs across the portfolio and schedules activities in accordance with line function and program/corporate goals/assignments and priorities supporting Discovery, Nonclinical and Clinical programs. Author Immunogenicity Risk Assessments and Biomarker Plans.
• 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 propose new strategies within the RD organization. Develops new methods and extends technology to drive applied science into new application areas.
• Provide bioanalytical representation on multiple cross-functional program teams. Act as a resource or provide guidance to colleagues.
• 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.

Research/identify/design and implement high complexity bioanalytical test methods and/or biomarker strategies.

Manage external vendors/CROs to meeting sample testing timelines

Represent Bioanalytical group on various cross-functional project teams

Performs high-level review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards.

Assesses progress relative to objectives and communicates progress periodically to supervisor and key stakeholders within and outside Group.

Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publication.

Education & Experience Requirements:
PhD in life science with more than 8+ years of industry experience.
• Experience in large molecule assessments for PK, toxicology and biodistribution studies as well as ADA and 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 in placing and managing external work at CROs/CMOs is required.

About Shire:
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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