Job Details

PV Scientist

The PV Scientist is responsible for all aspects of drug safety for assigned compounds across clinical development activities, ensuring patient safety and compliance with global regulatory reporting requirements. This role serves as the safety expert for company products at all stages of development (Phase 1, 2, 3, and post-approval) and actively participates in the oversight of patient safety across all ongoing clinical trials.

Key Responsibilities

• Safety Strategy & Signal Detection
• Lead risk management strategy, including signal detection through aggregate data analysis of company drug products.
• Lead or support drug safety committee meetings for routine signal detection and cross-functional alignment on safety topics.
• Perform research on safety profiles of competitor products within relevant therapeutic areas to inform competitive clinical development strategies.
• Clinical Safety Oversight
• Provide oversight of all clinical safety services, including medical review and management of SAEs from clinical trials.
• Determine and provide sponsor causality assessments.
• Provide expert safety review input into all critical clinical development documents (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical study reports, INDs, CTAs).
• Regulatory Compliance & Reporting
• Ensure compliance with SOPs and FDA, EU, and global regulations for reporting adverse events to regulatory agencies, IRBs/Ethics Committees, and Investigators.
• Lead or assist cross-functional teams in responding to regulatory authority safety inquiries, audits, and corrective action plans.
• Develop, prepare, and ensure compliance of periodic and annual safety reports (e.g., US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates), investigator communications, product labeling/package inserts, and related reports as necessary.
• Risk Management & Agreements
• Develop and maintain the Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategy (REMS), and Company Core Data Sheet (CCDS) as needed.
• Provide oversight of Safety Data Exchange Agreements (SDEA) or Pharmacovigilance Agreements (PVA) as needed.
• Provide safety support for business development activities as needed.

Minimum Requirements & Qualifications

• Education
• Bachelor's degree in scientific discipline required.
• Advanced degree such as PharmD or PhD is a plus.
• Experience
• Minimum of 12 years of relevant drug safety experience required.
• Experience as a safety lead for NDA/BLA approval is a plus.
• Experience in both small and large companies is advantageous.
• Knowledge & Skills
• Strong understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs governing drug safety and pharmacovigilance.
• Hands-on experience with safety databases, and expertise in clinical safety assessments, safety signal detection, and risk management, including interactions with regulatory authorities.
• Demonstrated ability to solve problems with innovative solutions, supported by strong organizational skills.
• Excellent written and verbal communication skills; experience conducting formal presentations to senior management and key opinion leaders is a plus.
• Knowledge of effective competitive strategies and in-depth understanding of clinical product development in the pharmaceutical industry.
• Strong analytical skills, particularly in understanding and interpreting scientific research and literature.
• Demonstrated self-starter and team player with strong interpersonal skills.

Travel Requirements

The employee may be required to travel up to 25% of the time within the U.S. and internationally. Attendance at meetings and congresses on weekends may be required.

Additional Information

Nektar currently anticipates the base salary for the Sr. Director, PV Scientist to range from $280,000 to $325,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at the Company's discretion. The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data. Qualifying employees are eligible to participate in benefit programs such as: Health Insurance (Medical/Dental/Vision) Disability Insurance Holiday Pay Paid Time Off (PTO) 401(k) Match Employee Stock Purchase Plan Wellness Programs Parental Leave Benefits (in accordance with the terms of applicable plans) For general information on company benefits, please go to