Shire Associate Director Toxicology in Cambridge, Massachusetts
The Associate Director of Toxicology is accountable for timely and effective drug safety support for programs in preclinical or clinical development and for marketed products support. The incumbent is expected to demonstrate competency in interpreting toxicology data, development and implementation of strategic plans for nonclinical development, as well as providing expertise and guidance in Regulatory Toxicology to project/program teams and Shire management. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The incumbent will be an active participant on project/program/product teams, as well as collaborating with Discovery leadership and assisting senior management in the identification and review of new business initiatives and in-licensing opportunities. The incumbent will adhere to established processes, policies and quality systems for outsourcing, managing and reporting regulatory toxicology programs, studies and other activities in support of Shire portfolio programs and to provide appropriate content and submission-ready documentation for the toxicology components of regulatory submissions.
Responsibilities (% of time):
Provide high-level advice to project/program/product teams and senior management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy.
Review and approve Toxicology study protocols, reports, associated
nonclinical summaries, Regulatory submission sections and associated documentation, as well as abstracts/manuscripts for publication.
Design, manage, analyze, review, summarize, interpret and report results of Toxicology and Safety Pharmacology studies.
Maintain up-to-date Toxicology plans (linked to overall NCD plan &
IDP) for all projects/programs/products, including listings of studies, timelines, status and costs; update and refine as necessary.
Provide scientific/technical due diligence support for Business
Development activities as required.
Prepare for and participate in regulatory agency interactions.
Bachelor’s or Master’s degree in a related subject.
•PhD in a related subject, with DABT certification preferred, but not required.
7+ years industry-related experience in regulatory Toxicology working within the pharmaceutical industry.
•Hands-on experience in all aspects of Toxicology study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology. Experience with biologics and gene therapies preferred.
•Experience representing function to global regulatory agencies in support of submissions ie, IND/CTA, CTD, IMPD.
•Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
Experience in the outsourcing and external oversight of nonclinical Toxicology studies conducted by qualified suppliers.
Experience with both small and macromolecular/biologic drugs is highly desirable.
Experience in providing formal scientific/technical due diligence support for Business Development activities highly desirable
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.