Sr. Manager, PV Scientist
- Employer
- Nurix Therapeutics
- Location
- Remote
- Start date
- Apr 29, 2022
View more
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Details
Company
Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.
Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.
Position
The incumbent supports all aspects of safety science, medical surveillance, and risk management activities for Nurix Products. Works cross functionally with internal (i.e., Clinical Development, Clinical Operations, Regulatory Affairs, and Data Management) and external stakeholders to monitor and maintain the safety profile of all Nurix products.
Responsibilities:
- In collaboration with Nurix physicians, provides medical surveillance and risk management activities for all Nurix products
- Author and compile pharmacovigilance aggregate reports (e.g., DSUR, PADER, PBRER) for all Nurix compounds and ensures all safety documents are submitted according to regulatory requirements
- Supports the development of Investigators Brochure (IB) and analyze data for the RSI section of the IB
- Supports authoring of study protocols and ICF
- Participates in new study initiation to ensure PV requirements are met including but not limited to safety reporting, query resolution, SAE reconciliation, and safety reporting training.
- Represents PV in cross-functional meetings and additional activities to support clinical development programs
- Leads signal detection activities for a products emerging safety profile and presents safety data
- Perform data analysis to evaluate safety signal and write up analysis results
- Write and analyze data for responses to health authority queries
- Supports process improvement and cross functional initiatives for safety science including SOPs and procedural documents
- Performs QC on cases processed by vendor and provides feedback to PV vendor
- Provides safety reporting training to internal Nurix employees and contracted vendors
- Contributes to the development of safety management plans and facilitates activities during study start-up phase, including cross functional interactions.
- Contributes to the development of safety governance structure
- Participates in audit/inspection preparedness activities and serve as subject matter expert during regulatory inspections
Required Qualifications
Minimum 5 years’ experience in Pharmacovigilance/Drug Safety environment and at least 3 years in PV/Safety Science
Bachelor’s degree in health-related discipline or equivalent (RN, R.Ph., Pharm D, or MD)
Experience with aggregate safety reporting (DSUR), safety surveillance, signal and/or risk management
Strong knowledge of US and International safety reporting regulations and requirements
Strong experience in case processing and QC of ICSR
Experience with the use of global safety database is required.
Experience leading safety data review meetings, creating agenda, and meeting minutes
Active participation in regulatory inspections and audits
Bonus Qualifications
Self-motivated, ability to take ownership of, and follow through with specific tasks
Ability to effectively communicate, collaborate, and excel in a fast-paced and rapidly growing department and organization
Highly organized with strong attention to details
Experience with clinical and post marketing safety activities
Fit with Nurix Culture and Values
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
Application Process
Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.
Company
Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.
Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.
- Website
- https://www.nurixtx.com/
- Phone
- 415-660-5320
- Location
-
1700 Owens Street
Suite 205
San Francisco
California
94158
US
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