Sr. Director, Drug Safety Operations

San Francisco, CA, United States
Sep 19, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Overall responsibility for leading the operational drug safety and pharmacovigilance process.

Manages compliance with SOPs and FDA regulations for the reporting of adverse events to regulatory agencies. Coordinates the development of guidelines and insures the uniform and timely processing of adverse event reports. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements. Directs the development and preparation of reports for company management as well as external regulatory agencies. Directs and conducts ongoing safety surveillance on company products. Directs the preparation of NDA Safety Updates, IND (Investigational New Drug) safety reports, investigator communications, Product Labeling/Package Inserts and other reports as necessary. Participates in oversight of on-going clinical trials and in the preparation of NDAs with respect to drug safety. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads all aspects of drug safety related to all Company sponsored clinical development activities. Provides strategic planning, implementation, and management of operations for drug safety to support clinical development and marketing. Ensures appropriate regulatory authority reporting, dissemination of safety information and actively contributes and guides drug development project teams. Directs the development of Core Data Sheets and prepares written safety summaries for inclusion in documents that contain safety sections. Provides Clinical Safety services including review of AE coding and SAE collection, assessment and reporting; prepare similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. May be responsible for providing regular performance feedback, development and coaching to direct reports.

A minimum of a Bachelors degree in a scientific discipline is required. An advanced degree such as a, PharmD, PhD or MD is preferred. Equivalent experience may be accepted. A minimum of 15 years experience in the pharmaceutical or other related industry with a minimum of 12 years drug safety experience is required. A minimum of 12 years previous management experience may be required. A thorough understanding of FDA regulations/ICH guidelines, knowledge of Drug Safety regulations, experience with safety databases is required. Must have a strong working knowledge of safety reviews for IB and final reports. Strong oral and written communication skills are required. Experience working in a team-focused environment is preferred. Good computer skills are required. Must be detail oriented.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.