Director, Drug Safety (MD)

Location
San Francisco, CA, United States
Posted
May 04, 2021
Ref
5343-512-R
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Director, Drug Safety (MD) to join their team.

Overall responsibility for leading and conducting safety surveillance and risk management activities for assigned drug products in Nektar's development pipeline. The Director, Drug Safety (MD) will help develop and train personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

RESPONSIBILITIES:

Conducts real-time medical review of individual case safety reports (ICSRs) received from ongoing clinical trials, including providing company causality assessments and similar-event analyses. Timely communication of AEs of special interest cases to clinical development teams. Serves as a mentor and potential manager for other safety medical reviewers and safety personnel. Monitors and analyzes evolving risk/benefit profile of the assigned products in various stages of clinical development to identify potential safety signals and implements appropriate safety monitoring and risk mitigation plans. May serve as a Safety Management Team chairperson. Provides ongoing advice to senior management on the risk-benefit profile of company drug products in clinical trial based on ongoing analyses/evaluation of potential safety signals. Closely collaborates with internal and external stakeholders including development partners on issues related to patient safety and safety deliverables. Develops and communicates potential pharmacovigilance and risk mitigation strategies as needed. Responds to safety queries from internal and external development partners, investigators, and regulatory authorities. Serves as a subject matter expert during internal and external audits including regulatory agency inspections. Aids with the creation of corrective action plans as needed. Provides medical expert safety review input into all critical documents for clinical development of the assigned products (e.g., Protocols, ICFs, IBs, IMPDs, CSRs, RMPs, INDs, CTAs, NDAs/BLAs, briefing documents, etc.). Leads the development and preparation of DSURs and safety sections of the IB including creation and maintenance of the referenced safety information (RSI). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) or internal safety data monitoring committee for clinical studies, if required.

REQUIREMENTS:

An MD degree is required. Minimum 7-years of experience in drug safety and risk management. Experience with oncology product development and regulatory submissions highly desirable. In-depth knowledge and thorough understanding of FDA and EU regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance. Experience and expertise in signal detection and risk management, including interactions with regulatory authorities. Experience with ICSR review and assessment, including analysis of similar events. Experience with using a safety database (e.g., Argus). Experience in preparing DSURs and safety sections of the IB including the RSI. Strong oral and written communication skills. Ability to solve problems with innovative solutions along with strong organizational skills. Strong analytical skills including understanding and interpreting scientific research and literature. Demonstrated self-starter and team player with strong interpersonal skills. Strong computer skills with a proficiency in various software applications (e.g., Microsoft Project, Word, Excel, PowerPoint).

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.