Jobs in Irvine, CA

About the role

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the  safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS.PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs.

What you'll bring

• Write, review and provide input on technical documents
• MD / DO with 2+ years of internal medicine residency with patient management experience required
• 2-5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
• Previous experience supporting regulatory submissions (IND/BLA submissions) is required
• Oncology patient safety experience is required
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations / opinions in group environment both internally and externally
• Work collaboratively and lead cross-functional teams
• Ability to lead cross-functional teams in a collaborative environment
• PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required

Benefits