Sr. Outsourcing Scientist, Toxicology

ROLE SUMMARY

Drug Safety R&D (DSRD) is a global organization that provides input into drug target selection, helps identify promising drug candidates, discovers and develops biomarker and screening assays, and leads the conduct and interpretation of toxicology studies in support of clinical development programs and registration. Within DSRD, Global Toxicology executes general and specialized toxicology study strategies to aid in compound selection and enable clinical development across all phases for all therapeutic areas and modalities, derisk and manage issues, and communicate key information to support decision making in the drug development process. The Outsourcing Scientist for Global Toxicology in Drug Safety Research and Development (DSRD) is responsible for ensuring contracts are in place, studies are awarded to the CRO and financials are recorded and reported for each study which enable key DSRD deliverables.

The successful candidate will be well versed in CP102, have a strong working knowledge of the MAPP processes and will be proficient in Business Objects to create and run ad hoc reports on vendor information contained in DSRDs Portfolio Information Management (PIMs) system. This individual would need to have a scientific understanding of the DSRD Standard Study Designs, the fundamentals of planning, conducting and reporting Toxicology studies, and a good understating of the DSRD vendors and capabilities to place work externally.

The candidate must be a self-starter who is able to multitask, perform functions with minimal supervision, operate across global sites and lines, and work in a fast-paced and dynamic environment. Expert interpersonal, Microsoft product user skills, and communication skills with the ability to influence and manage external individuals at multiple levels and functions in the vendor organization.

ROLE RESPONSIBILITIES

• Accountable for ensuring the quality of the financial data in PIMs and becoming an expert in maintaining the operating and functioning of PIMs to the needs of DSRD Outsourcing.
• Conduct, analyze and maintain CP102 due diligences as well as ensuring any other due diligence are scheduled/performed prior to using vendor (eg Cyber Risk assessments, MAPP due diligence).
• Management and documentation of all HCPs that DSRD utilizes with via the Engage system as part of R&D SOP 202.
• Collect and report out Outsourcing financial metrics for rollup to LT and ET.
• Have a clear understanding of what vendors DSRD utilizes for services. Utilize data provided by Resource Management, Vendor Relationship Manager and discipline lines to effectively identify and place nonclinical studies at CROs.
• Partner with Finance, Procurement and Business Development to ensure DSRD vendor info (financials, contract status, etc) is shared accurately across all lines.
• Clear understanding of DSRD standard protocol design and timing to effectively communicate needs for the work orders to the vendors when placing work.
• Provide mentorship and coaching regarding Corporate policy as it applies to DSRD outsourced work.

BASIC QUALIFICATIONS

• Bachelors (BS/BA) degree or equivalent in Business, Life Sciences, or Toxicology
• At least 5 years of Pharmaceutical business experience (eg relationship management, budget management, analytics, compliance reporting etc).

PREFERRED QUALIFICATIONS

• Familiarity with GLP regulations
• Experience working in or leading multidisciplinary teams
• Project management and budgeting experience
• Experience in performing or managing Toxicology studies

Other Job Details:

Last Date to Apply for Job: September 30th, 2021

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