Director, Drug Safety

Pionyr Immunotherapeutics, Inc., an expanding, well-funded South San Francisco-based clinical stage immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking an experienced and motivated Director, Drug Safety. This pivotal role, based at our South San Francisco location, will report to our Medical Director, Clinical Development, and be accountable for all aspects of drug safety in support of our drug development programs. 

Specific Responsibilities include (but not limited to):

• Monitors and analyzes evolving risk/benefit profile of the assigned immuno-oncology products in various stages of clinical development to identify potential safety signals and implement appropriate safety monitoring and risk mitigation plans.
• Provides ongoing advice to senior management (ad hoc or through periodic safety review committee meetings) and the project team on the evolving risk-benefit profile of drug products in clinical trials, based on analyses/evaluation of potential safety signals, and implements appropriate safety updates and risk mitigation strategies.
• Serves as the safety expert for the assigned products in clinical development as well as pre-IND stage products. Leads response to and resolution of safety questions from regulatory authorities, investigators, internal development teams, and external development partners; may represent Pionyr in direct engagements with regulators.
• Develops, contributes to, and oversees the execution of the signal detection strategy for the Pionyr portfolio. Develops standardized methods and processes of surveying safety data from ongoing clinical trials.
• Develops and manages the Pionyr core safety information (core data sheet) initiative and associated supporting procedures and documents.
• Closely collaborates with internal stakeholders such as clinical research, clinical operations, translational research, clinical pharmacology, regulatory affairs, quality assurance, biostatistics, data management, project management, toxicology, bioinformatics, and biomarker teams to deliver excellence in drug safety and appropriate assessment of risk to trial participants.
• Conducts real-time medical review of individual safety reports received from ongoing clinical trials, including providing Pionyr causality assessment and similar-event analyses, and timely communication of AEs of special interest cases to management and clinical development and project teams.
• Manages pharmacovigilance activities across all clinical studies, in partnership with external contract organizations.
• May develop and/or negotiate safety contracts & safety data exchange agreements, interacts and coordinates activities of contract organizations or consultants for drug safety services.
• Establishes and manages independent safety assessment review committees and/or internal safety review committees for clinical studies. This includes identification and cultivation of key opinion leader relationships, establishment of charters and appropriate documentation of meeting minutes.
• Reviews reconciliation SAE data between clinical and safety databases.
• Manages the aggregation of data for safety signal detection, for its analysis and the appropriate reporting, including Developmental Safety Update Report (DSUR) and other periodic safety line listings, as required.
• Leads or contributes to the development and preparation of annual or periodic safety reports (e.g., AR, DSUR, PSUR).
• Is an active partner and core contributor of safety input to key regulatory or clinical documents including, but not limited to:
  • Product Labeling
  • Risk Management Plans
  • Safety Management Plan
  • Clinical Trial Protocols
  • Informed Consent Forms
  • Safety Sections of Investigator’s Brochure 
  • Clinical Study Reports
  • Briefing Documents
  • Health authority queries
  • Integrated Safety Summary & Summary of Clinical Safety for NDA/BLA/MAA filings
  • Core Data Sheets
• Recognizes and escalates significant issues relating to compliance, budgets, timelines, or other issues that jeopardize business objectives.
• Contributes to scientific publications (abstracts, posters, papers) for scientific meetings and/or journals.

Requirements 

• A minimum of 7 years of experience in drug safety/pharmacovigilance in the clinical development setting is required.
• Advanced healthcare degree (e.g., M.D, PhD, DO, PA) or professional qualification in a health science field (e.g., nursing or pharmacy, RN, NP, PharmD)
• Experience and expertise in oncology antibody drug 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.
• Full knowledge of US and EEA compliance regulations and guidance on medical information practices; experience developing drug safety or medical information SOPs.
• Experience and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities, are required.
• Experience in preparing annual and aggregate safety reports (eg, AR, DSUR, PSUR) is required.
• Experience in validating (including UAT), and using safety databases (e.g., Argus) to perform review of individual case safety reports, is highly desirable.
• Ability to use and understand MedDRA and WHODRUG coding dictionaries, assisting the Medical Director in data coding listing reviews, and ensuring consistency of coding across Pionyr clinical programs.
• 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.
• Must have strong computer skills with a proficiency in various software applications (e.g., Microsoft Project, Word, Excel, Visio, PowerPoint).
• Excellent interpersonal, communication, analytical, and organizational skills.
• Excellent oral and written skills; ability to effectively communicate complex information.
• Ability to analyze & interpret clinical data.
• Ability to work independently and on a team, effectively collaborating with internal and external stakeholders.
• Ability to proactively resolve issues and make sound decisions.
• Flexibility to respond rapidly and effectively to changing priorities.
• Strong organizational abilities and attention to detail.
• Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment.
• Respected subject matter expertise. 
• Risk management experience.  
• Proven knowledge of ICH, FDA, IRB/IEC, and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements 
• Ability to work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes. 
• Experience in establishing and maintaining relationships with suppliers. Effectively partner with CxOs in pursuit of positive outcomes for Pionyr. 

Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume.

Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.