Perform all regulatory responsibilities in compliance with applicable regulatory standards.
Strategic activities of projects:
1.Attend Project Team meetings, develop expertise in project area, and engage on all related aspects of the project e.g., efficacy, druggability, and clinical safety
2.Attain knowledge of the target, awareness of the competition, and knowledge of global regulatory guidelines
3.Early Project Teams (targets). DSTLs
Serve as the DSRD POC for exploratory/target identification and selection activities for an individual target.
Work with appropriate SMEs in DSRD and elsewhere to identify potential target safety risks, place them into appropriate context for the indication and proposed patient population, and develop a target de- risking strategy.
Interact with DSRD and other SMEs as needed to execute the target safety de-risking studies.
Periodically review emergent information and data sets for the target, incorporating new information (internal and external) into the TKR.
4.Design nonclinical safety strategy and Toxicology Plan for SDS-FIH and FIH-Registration studies in association with DSRD TAL and schedule required studies to meet Project timelines. Coordinate amount and delivery of API with Pharm Sci. Maintain information current in Portfolio Information Management System (PIMS)
5.Prepare DSRD portions of CAN and similar documents, and regulatory dossiers (IND/IMPD, NDA/MAA etc) and regulatory query responses in collaboration with RSC.
6.Represent DSRD at project-related Regulatory Agency meetings (e.g., pre-IND, EOP-II, Pre- NDA)
7.Coordinate FIH decision consensus process (prepare and present Toxicology Review of findings)
8.Communicate Project status, progress, and potential impediments to DSRD TAL
9.Issues management work with TAL and other DSRD experts as appropriate, to develop de-risking strategies for Toxicology issues.
Coordinating tactical activities for studies:
1.Study design (including dose selection), especially identifying compound-specific issues that will need to be addressed in studies.
2.Coordinate with Study Director (SD), details of specific studies and resources.
3.Prepare study request form and review protocol in collaboration with SD, including dose selection and study-specific requirements.
4.Ensure alignment of API delivery in accordance with study timelines.
5.Conduct study design meeting, as appropriate.
6.Monitor study progress and update DSRD TAL, and present study results to Project Team.
7.Serve as the study monitor, i.e. scientific and technical representative for outsourced studies from their projects within their area of expertise. Address issues that arise during the study, interact effectively with the SDs at the CRO; conduct timely review of data during the study to be aware of trends and identify issues/concerns; conduct timely review of the draft report to ensure that conclusions are aligned with data. DSTL will coordinate with STRs for studies outside their area of expertise
Ph.D, DVM, or MS with at least 3 years pharmaceutical industry experience.
Minimum of 2 years relevant experience depending on project's stage in development
Demonstrated ability to work collaboratively in a matrixed, multi-line environment
Some experience with Gene Therapy programs desired
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Other Job Details:
Eligible for Relocation Package: yes
N (Other) (United States of America)
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