Associate Director, Safety Sciences

Role Summary

Associate Director, Safety Sciences. Serve as a safety science expert to support the development of Olema’s products. Collaborate with cross-functional teams and external stakeholders.based in San Francisco or Boston with <10% travel.

Responsibilities

• Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment
• Perform signal evaluation for identified safety signal and author safety evaluation reports
• Manage preparation and completion of safety documents, including DSURs, PADERs/PBRERs, RMPs, and safety sections of protocols, reference safety information for IBs, ICFs, briefing books, NDA, and CCDS, etc.
• Participate/lead responses to regulatory inquiries and other risk management activities
• Support clinical/medical review of SAEs, AESI, SUSARs, and AOSE, including reviewing source documents, case narratives, MedDRA coding, queries, event expectedness, sponsor assessment, and assisting Safety Operations staff
• Conduct literature searches and develop search strings for review information
• Support and attend Data Monitoring Committee (DMC) meetings
• Support quality systems, inspection readiness, audits, and inspections
• Participate in process improvement initiatives and SOP maintenance
• Collaborate with cross-functional teams and external stakeholders, including business partners and safety vendors/contractors
• Lead and facilitate safety team meetings with effective communication
• Apply FDA, EU, and ICH guidelines governing pharmacovigilance activities

Qualifications

• Required: MD, PhD in medical/biological science, PharmD, or RN; Small Molecule and Oncology experience
• Experience: 5+ years (MD/PhD/PharmD) or 8+ years (RN) in pharmacovigilance/drug safety in biopharma; process improvement and SOP development experience; ability to apply regulatory guidelines; experience with safety vendors; familiarity with safety database/EDC; mentoring experience
• Attributes: time management, strong written/spoken communication, analytical/problem-solving skills, self-motivated, ethical judgment

Skills

• Pharmacovigilance, signal detection, safety data analysis
• Regulatory submissions and safety documentation
• Medical review of SAEs/AESI/SUSARs; case narrative reviews; MedDRA coding
• Literature searching; DMC collaboration
• Cross-functional collaboration; vendor management
• Safety database/EDC proficiency

Education

• MD, PhD, PharmD, or RN degree (as applicable)

Additional Requirements

• Role based in San Francisco or Boston; <10% travel