Director, Drug Safety (MD)

Overall responsibility for leading the safety surveillance and risk management of the assigned drug products in Nektar’s development pipeline or post-marketed product(s) for managing patient safety and meeting regulatory reporting requirements.  

RESPONSIBILITIES: 

• Monitors and analyses evolving risk/benefit profile of the assigned immuno-oncology products in various stages of clinical development to identify potential safety signals and implements appropriate safety monitoring and risk mitigation plans.   
• Serves as medical safety expert for the assigned products in early and late stages of clinical development as well as in pre-IND stage products.  Leads role to help respond to and resolve safety questions from regulatory authorities, investigators, internal development teams, external development partners as well as regulatory agency audits and corrective action plans. 
• Closely collaborates with various internal stakeholders such as clinical operation, clinical development, clinical pharmacology, regulatory affairs, biostatistics, data management, project management, toxicology teams as well as external development partners to ensure delivery of quality pharmacovigilance and meet all regulatory obligations and company SOP requirements.  
• Leads or contributes to the development and preparation of periodic safety reports (eg, DSUR and PSUR), response to safety-related queries from health authorities, investigator communications, and other ad hoc reports as necessary.  Provides medical expert safety review and input into all critical documents for clinical development and regulatory filings of the assigned products, including investigational brochure, study protocol, informed consent form, briefing documents, clinical study report, risk management plan, product labeling, and IND/NDA packages. 
• Conducts real-time medical review of individual clinical safety reports (ICSRs) received from ongoing clinical trials, including providing company causality assessment and similar-event analyses, and timely communicates AEs of special interest cases to clinical development teams.
• This position helps select, 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.
• Develops and/or negotiates safety contracts, safety data exchange agreement, interacts and coordinates activities of contract organizations or consultants for pharmacovigilance services as well as developmental/business partners.
• Provides ongoing advice to senior management (ad hoc or through periodic safety review committee meetings) on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation strategies.
• Provides medical expert safety review input into all critical documents for clinical development of the assigned products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, risk management plan, INDs, CTAs, NDAs/BLAs, briefing documents, etc).
• Establishes and manages independent Data Safety Monitoring Boards (DSMBs) or internal safety data monitoring committee for clinical studies, if required.
• Performs literature research on safety profiles of competitor immuno-oncology products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products.

REQUIREMENTS: 

An MD degree is required. A minimum of 7 years of experience in drug safety and risk management in clinical development setting is required. Experience and expertise in oncology product development and drug safety is highly desirable. An in-depth knowledge and thorough understanding of FDA and EU regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience/knowledge in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Experience in using safety database (e.g., Argus) to perform medical review of individual case safety report is highly desirable. Experience in preparing aggregate safety reports (eg, DSUR, PSUR/PBRER) is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical/biotech industry. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills and good understanding professional responsibilities. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Must be a demonstrated self-starter and team player, good collaborator with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, PowerPoint).