Associate Director, Safety Scientist

Lead end-to-end safety science activities, including signal detection, evaluation, and risk assessment across clinical and marketed oncology products, ensuring alignment with global pharmacovigilance standards.

• Identify, analyze, and evaluate safety signals from multiple data sources and determine their potential impact on benefit-risk profiles and product labeling.
• Develop and execute safety data analysis strategies and author comprehensive safety evaluation reports.
• Collaborate with cross-functional teams including safety physicians, epidemiologists, and clinical scientists to ensure robust safety assessments.
• Lead preparation and presentation of safety findings for governance committees, including safety management and review boards.
• Oversee safety input for clinical trial documents such as protocols, IBs, ICFs, SAPs, CSRs, and regulatory submissions.
• Contribute to risk management plans, regulatory responses, and periodic safety reporting (e.g., DSURs, PADERs).
• Support signal detection and documentation processes in compliance with internal and external regulatory requirements.
• Provide safety expertise for investigator interactions, training, and global safety communications.
• Ensure timely communication of safety insights to internal stakeholders and external regulatory bodies.

Requirements:

Advanced scientific or medical degree required (PharmD, PhD in biological/medical sciences, or MD preferred), with relevant clinical or safety experience.

• 4+ years of experience in pharmacovigilance, clinical safety, clinical development, or related analytical roles in the pharmaceutical or biotech industry.
• For RN candidates, 8+ years of pharmacovigilance experience in an analytical capacity is required.
• Strong understanding of safety science principles, signal detection methodologies, and benefit-risk evaluation frameworks.
• Experience in oncology or hematology drug development is strongly preferred.
• Knowledge of regulatory requirements for safety reporting and global pharmacovigilance standards (ICH guidelines).
• Strong analytical thinking and ability to interpret complex clinical and safety datasets.
• Excellent communication skills with the ability to present scientific findings clearly to cross-functional and governance teams.
• Proficiency in safety databases, MedDRA coding, and data analysis tools (e.g., Excel, Spotfire).
• Ability to operate effectively in a matrixed, global, and fast-paced environment.
• Strong attention to detail, scientific rigor, and decision-making capabilities.

Benefits:

• Competitive annual salary ranging from $154,300 to $204,300.
• Eligibility for annual bonus programs and incentive compensation plans depending on role type.
• Equity opportunities through discretionary stock awards and employee stock purchase plan.
• Comprehensive medical, dental, and vision insurance coverage.
• 401(k) retirement savings plan with additional financial benefits.
• Flexible spending accounts (FSA/HSA) and life insurance coverage.
• Paid time off and wellness programs supporting work-life balance.
• Exposure to global oncology programs and high-impact drug development initiatives.
• Inclusive, mission-driven culture focused on innovation, collaboration, and patient impact.