Toxicology Study Director, II
Toxicology Study Director, II
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 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 toxicology studies (80% of time) and external sponsor monitor for studies conducted at contract research organizations (< 20% 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 Good Laboratory Practice (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.
Manages study timelines against regulatory filing needs and in coordination with line function management.
Demonstrate the ability to resolve key planning and study conduct issues by effectively utilizing available information and technical expertise.
POSITION ACCOUNTABILITY / SCOPE:
Responsible for representing Sponsor in all aspects of GLP compliance within assigned studies and related departmental activities. Design conduct and report toxicology studies appropriate to overall development plans and aligned with regulatory expectations.
Apply external scientific and regulatory information to business practices and Toxicology strategies.
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.
Qualifications :
- Strong verbal and written communication skills to effectively communicate scientific data issues and conclusions; ability to work collaboratively within small teams and in a matrix reporting structure environment; lead scientific issue identification and resolution.
Basic Qualifications:
- Responsible for GLP and non-GLP study conduct and project science within his/her area of expertise. Demonstrates Toxicology expertise with agility accountability and excellent communication skills. Demonstrates the ability to resolve study design and regulatory issues and key study conduct hurdles 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 Requirements
- PhD or equivalent in Toxicology or closely related field with or without post-doctoral training and at least 4 years toxicology study director experience in pharmaceutical or contract research organization setting is preferred.
- Bachelors Degree or equivalent education and typically 10 years of relevant experience Masters Degree or equivalent education and typically 8 years of relevant experience may also be considered.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
