Senior Scientist II/Principal Research Scientist I, Toxicology Study Director
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
This position is in the Toxicology line function within the Preclinical Safety group and will report to the Director, Associate Director or a Sr. Group leader in Toxicology. This role designs, conducts and reports non-GLP and GLP in vivo general toxicology studies in support of drug submissions to regulatory agencies, and requires demonstrated effective written and communication skills.
CORE JOB RESPONSIBILITIES:
The primary responsibility of this job is to function as GLP Study Director for AbbVie internally conducted in vivo toxicology studies (90 % of time) and external sponsor monitor for studies conducted at contract research organizations (< 10% of time).
As Study Director, the incumbent ensures the highest standards in quality and regulatory compliance are met in study conduct and reporting. Accountable for all aspects of GLP report authorship, including writing and reviewing toxicology study reports and preparing assigned components of filing documents that support submissions to global regulatory agencies for drugs in development.
Serve as scientific expert for studies, during audits and on project teams, committees and other assignments. Accurately identify key scientific findings and effectively communicate findings in reports, presentations, and meetings.
Demonstrate the ability to resolve key project study and assumptions by effectively utilizing available information and technical expertise.
POSITION ACCOUNTABILITY / SCOPE:
Responsible for all aspects of GLP compliance within assigned studies and related departmental activities. Design, conduct and report in vivo general toxicology studies appropriate to overall development plans and aligned with regulatory expectations.
Apply external scientific and regulatory information to development strategies and business practices.
The Toxicologist must design/critically evaluate and interpret experiments, record, tabulate and report results and significant issues. The Toxicologist must understand and follow established procedures and practices, ensure compliance with established procedures within the function, as well as possess a good understanding of appropriate FDA, ICH and OECD regulations and guidelines. The level of this opportunity will be commensurate with experience. The position could be a Sr. Scientist III, Toxicology depending on experience.
Strong verbal and written communication skills to effectively communicate scientific data, issues and conclusions; work within small teams and in a matrix reporting structure environment; lead scientific issue identification and resolution.
Responsible for GLP and non-GLP in vivo toxicology study conduct and project science within his/her area of expertise on one or more project teams. Demonstrates Toxicology expertise with agility, accountability and excellent communication skills. Demonstrates the ability to resolve study design and regulatory issues and key project hurdles and assumptions by effectively utilizing available information and technical expertise. Effective writer and communicator of research or other regulatory materials. Proactively seek relevant information in the literature and incorporate this into knowledge of Toxicology practices and overall program issues.Education/ Experience Requirements: Principal Research Scientist I: BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in Toxicology closely related field and toxicology study director experience in pharmaceutical or contract research organization setting is REQUIRED Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies. Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals. Recognized and sought out as an expert in his/her discipline within the company and possibly externally. Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents. Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.
Senior Scientist II:Bachelor’s Degree or equivalent education and typically 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience. Possess thorough theoretical and practical understanding of own scientific discipline. Effective writer and communicator of research or other regulatory materials.
Job level will be commensurate with experience
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.