Enliven Therapeutics

Director

• Develop and execute the global pharmacovigilance strategy to align with company goals and evolving regulatory requirements
• Ensure the company complies with all global drug safety and reporting regulations (e.g., FDA, EMA, ICH) and implement necessary process updates.
• Lead, manage, and develop the pharmacovigilance team, fostering a culture of continuous improvement.
• Work closely with both internal and external stakeholders, including but not limited to Clinica Development, Regulatory Affairs, Quality Assurance, and Medical Affairs, to provide integrated safety oversight and ensure effective and timely monitoring, oversight, communication, and risk mitigation of emerging safety signals
• Lead safety and pharmacovigilance activities for all company products marketed and in development including ICSR review, periodic safety surveillance activities, safety issue work-up, preparation o DSUR, PADER, PBRER, etc. and authoring relevant safety sections of clinical documents including protocols, IB, ICFs, CSR etc
• Provide oversight of safety vendors to ensure all pharmacovigilance commitments are delivered and timelines are followed and manages the budget for these activities
• Evaluate and interpret safety data from pre-clinical studies, clinical studies, literature, and post-marketing information etc. to develop safety profile of company products
• Provide benefit/risk assessment on potential safety signals as needed
• Lead internal Safety Review Committees for all company products, and lead the identification and assessment of safety signals and development of action plans as needed
• Work with vendors to prepare/review all safety relevant operational documents, including SMP, SAE reconciliation plan, medical monitoring plan, data management plan etc.
• Collaborate with business partners on development of PVAs and ensures compliance with PVAs
• Provide safety related due diligence for business development opportunities.
• Support/Lead development of pharmacovigilance plans / risk management strategies etc.
• Establish department structure, processes, and procedures, responsible for hiring / training new employees
• Collaborate with QA for audit and inspection readiness

Senior Director, Head of Drug Safety and Pharmacovigilance

Compliance

• Leads project teams in implementing and delivering the regulatory strategy across multiple early and/or late-stage programs
• Develop Regulatory Strategy for complex programs in oncology
• Participates in cross-functional teams as regulatory project lead, providing regulatory strategic guidance and support
• Proactively defines and identifies regulatory risk and mitigation plans in support of product development plans
• Drives health authority interactions, including planning, briefing material development, and meeting preparation leadership
• Monitors changes in the regulatory environment, both general and specific to the therapeutic area and supports and advises Development Teams accordingly
• Independently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities
• Partners with external vendors in support of regulatory document preparation and submission
• Leads and executes non-project regulatory activities
• Demonstrates capability and credibility in complex, business critical projects as well as ability to cope with ambiguity and manage key stakeholders.

Senior Director, Global Regulatory Affairs

Communications

• Serve as the strategic and creative hub for all corporate communications, reporting to the CFO
• Create, curate, and disseminate media and investor content such as presentations, website content including engaging graphics and design, byline articles, business reports such as 10K, and other public release materials
• Partner closely with senior leadership to craft and deliver messaging across investors, media, and the broader public
• Develop and lead initiatives to promote and safeguard Enliven’s brand and reputation, managing media relations
• Coordinate communications across internal groups and collaborate cross-functionally to ensure alignment and visibility
• Proactively pitch story ideas and secure media placements in relevant publications
• Maintain calendar of events, publications, key timeline dates for material/content creation, announcements, and key social media dates
• Review, edit, and finalize materials to ensure flawless final product
• Assist with investor materials and coordinate IR communications, tracking investor engagement, shareholder activity, analyst sentiment and competitive intelligence
• Closely follow Enliven’s clinical and financial progress to shape corporate narrative and ensure compliant messaging

Director, Corporate Communications

Accountant

• Process invoices with accurate coding and approvals
• Generate Purchase Orders and process New Vendor Request Forms, obtain W-9s, and maintain vendor files
• Follow-up with vendors to obtain invoices and resolve issues; monitor AP and Purchase Order status
• Ensure day-to-day AP tasks are completed to meet accounting deadlines, including weekly payment runs
• Process bi-weekly and off-cycle payroll runs; review W-2s, 1099s and other year-end documents
• Answer employee questions about pay, deductions and other payroll-related issues; coordinate with HR for hires/terminations/benefit changes
• Assist with month-end close activities, prepare journal entries and account reconciliations
• Process employee expense reports and reconcile company credit card statements
• Maintain compliance with SOX internal controls and provide auditors with documentation for SOX/audit testing
• Assist in preparation of prepared-by-client (PBC) schedules for quarterly reviews and annual audit
• Track and prepare Use Tax filings and complete special projects/reports as requested by management

Senior Director, Head of Drug Safety and Pharmacovigilance

Senior Director, Global Regulatory Affairs

Director, Corporate Communications

Staff Accountant