Senior Director, Safety Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide scientific direction for safety surveillance and risk management throughout the clinical development portfolio.

• Lead safety science initiatives for assigned development programs and offer strategic insights into benefit-risk assessment.

• Create and uphold Safety Surveillance Plans (SSPs).

• Conduct signal detection and management activities, including upkeep of the signal tracker.

• Assist in literature surveillance to identify, assess, and communicate potential safety signals.

• Execute MedDRA SMQ and Preferred Term searches for adverse events of clinical significance.

• Collaborate with internal stakeholders to utilize visualization tools like Spotfire for safety signal detection and analysis.

• Draft Signal Analysis Reports (SARs) for validated signals and aid in risk characterization and mitigation strategies.

• Prepare presentations for Drug Safety Monitoring Team meetings.

• Develop scientific materials for safety-oriented advisory boards and Key Opinion Leader meetings.

• Create and maintain Development Risk Management Plans (dRMPs) and Development Core Safety Information (DCSI).

• Provide safety expertise for Investigator’s Brochures, clinical protocols, informed consent forms, DSURs, and other regulatory documents.

• Contribute to PV dashboards and ensure prompt communication of pertinent safety science information.

• Write and update Safety Science SOPs, work instructions, and signal/risk management procedures.

• Assist with safety-related inquiries from health authorities, IRBs/ECs, and Clinical Trial Applications.

• Collaborate across functions to incorporate safety insights into clinical development strategies, regulatory submissions, and critical program decisions while enhancing safety science processes.

• Report to the VP, Head of Clinical Safety & Pharmacovigilance.

⛳️ Requirements

• An advanced degree in Life Sciences, Pharmacy, Nursing, or Medicine (PharmD, Ph.D.) is required; MDs will also be considered.

• Over 12 years of experience in pharmacovigilance, drug safety, or safety science within the biotechnology or pharmaceutical sector.

• Extensive experience in supporting clinical-stage development programs.

• Proficiency in safety surveillance, signal detection and management, benefit-risk assessment, and safety risk management across various clinical development phases.

• Experience in drafting SSPs, SARs, dRMPs, DCSI, IBs, DSURs, clinical protocols, and informed consent forms.

• Experience in facilitating regulatory interactions and preparing responses to global health authorities regarding safety topics.

• Strong understanding of global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH requirements.

• Familiarity with safety databases, MedDRA coding, SMQs, and safety data visualization and analytics tools like Spotfire.

• Capability to lead complex cross-functional projects and influence decision-making without direct authority in a highly matrixed environment.

• Prior experience in oncology, rare diseases, immunology, or other specialized therapeutic areas is preferred.

• Basic proficiency with AI tools for daily tasks; advanced or innovative use of AI is a significant advantage.

🏝️ Benefits

• Annual target bonus

• Equity

• Comprehensive suite of competitive benefits designed to support employees’ overall well-being