Associate Director, Drug Safety

Location
San Francisco, CA, United States
Posted
May 23, 2021
Ref
5333-512-NB
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for an Associate Director, Drug Safety to join their Drug Safety team.

Manages the 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. Manages the development and preparation of reports for company management as well as external regulatory agencies. Manages 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 NDA's with respect to drug safety.

Establishes operational objectives and work plans. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations(s).Works on issues where analysis of situations or data require an in-depth knowledge of organizational objectives, as well as an understanding of the business. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and ensures adherence to budgets, schedules, work plans and performance requirements. Regularly interacts with senior management or executive levels. Directs the aspects of drug safety related to 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 10 years experience in the pharmaceutical or other related industry with a minimum of 5 years drug safety experience is required.A minimum of 8 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.