Position Title: Director, Safety Operations

Job Status: Exempt - Part Time

Location: Remote

Department: Pharmacovigilance (Clinical Development)

Company Overview

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs.

Summary

Enliven is seeking a Safety Operations Lead who will be responsible for oversight of safety operations activities with external partners and vendors, including implementing safety reporting processes and directives, monitoring compliance with internal standard operating procedures, overseeing adverse event case management, oversight of the drug safety database, providing support to study teams and projects. The opportunity is a key addition in providing direction to the Drug Safety (DS) department and will report to the VP, Clinical.

Responsibilities:

• Oversee the duties and responsibilities performed by Data Safety Pharmacovigilance (DSPV)
• Physician and Pharmacovigilance (PV) Operations consultants, and full service DSPV service
• provider(s) handling activities such as case-processing, submissions, and safety database hosting.
• Leads the implementation and oversight of the procedures performed by service provider(s) regarding the receipt, processing, management, and reporting of individual safety case reports (ICSRs) to ensure compliance with corporate and regulatory requirements.
• Accountable for oversight of any safety-related activities carried out by service provider(s) on Enliven Therapeutics behalf. Assesses the vendor’s service quality, compliance, and performance in a risk-based manner as it impacts the PV System and in compliance with applicable laws, regulations, and Good Pharmacovigilance (GVP) provisions.
• Leads the development of the study specific safety management plans (SMPs) with service provider(s) and partners.
• Responsible for contractual agreements of pharmacovigilance vendors (e.g. PVA/PVMP/SMP) and partners (SDEA)
• Monitors metrics/key performance indicators (KPIs) to assess service provider(s)’ performance and compliance with the requirements of the SMPs and/or contracts.
• Collaborates with DSPV Physician on development and implementation of signal detection plan
• Leads the establishment, implementation, and management of the Safety Surveillance Executive
• Committee (SSEC) and their activities, including activities that monitor safety signals and mitigation plans to promote patient safety and compliance with global safety regulations.
• Conduct safety data review and analysis, summarize safety data in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities
• Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities
• Collaborate with DSPV Physician and Clinical Development to develop and maintain Core Safety Information/Reference Safety Information, as appropriate, and communicate identified risks to applicable internal and external stakeholders, as appropriate
• Provide oversight and assist in preparation and review of key pharmacovigilance document such as Drug Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Reports, Periodic Safety Update Reports, Risk Management Plans and safety sections of Investigator Brochures (IB), Informed Consent Forms (ICF) and clinical trial/study protocols and final reports in accordance with legal requirements, respective SOPs, and Health Authority expectations
• Perform gap analysis of the DSPV function/department to establish procedures, SOPs, and/or roles for the DSPV infrastructure.
• Experience with (Argus) safety database establishment and implementation
• Support SAE reconciliation activities for all Enliven Clinical Trials
• Overall responsibility for the quality and compliance of DSPV processes and PV system
• Lead Regulatory Inspections for PV Operations and Risk Management activities

• Advanced Degree: Minimum of 5+ years of experience in drug safety operations, ideally within the oncology therapeutic area with small molecule experience
• Vendor Management Expertise: Proven experience in overseeing and managing safety vendors is essential
• Technical Proficiency: Strong expertise in utilizing safety databases and safety coding dictionaries
• Global Safety Reporting: In-depth knowledge of international safety reporting regulations and best practices
• Regulatory Acumen: Comprehensive understanding of and ability to implement pre- and post- marketing drug safety standards, particularly in oncology
• Communication Skills: Exceptional oral and written communication skills, enabling clear and effective information exchange
• Team Collaboration: Strong interpersonal skills with a demonstrated ability to work collaboratively within cross-functional teams
• Project Management: Ability to manage multiple projects and meet tight deadlines with a high degree of accuracy and efficiency
• Strong ethics to approach programs with thoughtful and practical solutions

The expected salary range for this position is $205,000 - $255,000, prorated for part time work. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.