Associate Director, Safety Sciences

Role Summary

Associate Director, Safety Sciences – Safety science expert supporting development of Olema’s products, collaborating with cross-functional teams and external partners. Based in San Francisco or Boston with less than 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, expectedness, sponsor assessment, and assisting Safety Operations
• Conduct literature search activities and develop key strings for search criteria and review information
• Support and attend Data Monitoring Committee meetings, as required
• Support quality systems, inspection readiness, audit, and inspections
• Actively 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 biopharmaceuticals; process improvement and SOP/document support; ability to apply FDA/EU/ICH guidelines; experience with business partners and safety vendors; experience with safety database/clinical database/EDC; mentoring/junior team experience
• Attributes: strong time management, communication, analytical, problem-solving, strategic planning, interpersonal skills; self-motivated, fast learner; sound judgment and professionalism

Education

• MD, PhD in medical/biological sciences, PharmD, or RN degree

Additional Requirements

• No explicit travel beyond less than 10% required