Associate Director, Safety Operations
Olema Oncology
Full-time
Remote friendly (Boston, MA)
United States
Operations
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Role Summary
Associate Director, Safety Operations — In this role, you will support the daily operations of the Safety team, oversee safety reporting compliance, and solve complex project management issues. The position may be based in San Francisco, CA or Boston, MA with 5% travel.
Responsibilities
- Ensure timely and accurate processing of safety reporting to regulatory authorities, investigators, ethics committees, and business partners within timelines and according to SOPs
- Manage safety reporting compliance
- Draft and review pharmacovigilance documents
- Prepare and report safety-related metrics to upper management
- Collaborate with Clinical Operations, Data Management, Biostatistics, CROs, and business partners; participate in cross-functional meetings
- Manage vendors, maintain audit and inspection readiness, support pre-launch, pre-commercial and commercial launch activities, and NDA safety operations
- Assist with study start-up and management of new/future studies
- Spearhead development of departmental systems including SOPs and guidelines
- Perform SAE Reconciliation
- Train internal and external groups in Pharmacovigilance principles and best practices
- Work with safety vendors on daily operations tasks and implement key action items
Qualifications
- Required: BA/BS degree in life sciences, pharmacy, nursing, or related field; 7–10 years of pharmaceutical industry experience with at least 5 years in safety
- Preferred: Broad clinical/medical knowledge, pharmacovigilance expertise, and technical system proficiency; strong understanding of global pharmacovigilance regulations (EU/US/Canada), clinical trial methodology, and GCP
- Must have experience managing external vendors and ensuring audit/inspection readiness; pre-commercial and commercial launch readiness
- Strong organizational, project management, technical, and problem-solving skills
- Excellent presentation, communication, and interpersonal skills; strong written and verbal communication
Skills
- Independent work with initiative and flexibility
- Process and system improvement in drug safety
- Confidentiality and high ethical standards
- Cross-functional collaboration and strong verbal/written communication
Education
- BA/BS in life sciences, pharmacy, nursing, or related
Additional Requirements
- 5% travel; role may be based in San Francisco, CA or Boston, MA