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Director, Drug Safety

Nektar Therapeutics

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Location: San Francisco, CA Posted Date: 4/25/2013 Position Type: Full time Job Code: 2746-340-R Required Education: Bachelors Degree Areas of Expertise Desired: Drug Safety

Description


Directs 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.

Participates with other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures objectives are achieved. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements. Directs 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

Requirements

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 13 years experience in the pharmaceutical or other related industry with a minimum of 8 years drug safety experience is required. A minimum of 10 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.

When applying for this position, please mention that you found this opportunity on BioSpace.

Nektar Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar's research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates. Its drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a drug for the patient.



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