Position: Senior Medical Director, Head of Safety and Pharmacovigilance

Status: Full-time, exempt

Location: Remote

About Us

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

Role Summary:

We are seeking a head of drug safety & pharmacovigilance to be responsible for the implementation, execution and management of pharmacovigilance and risk management activities as part of the company’s product development and commercialization strategy. This role oversees product safety strategy and pharmacovigilance / risk management systems and activities. The successful candidate will interface with across all functional areas and is responsible for the establishment of pharmacovigilance procedures and processes for the ongoing development of product safety profile and oversight for all pharmacovigilance operational activities to ensure patient safety and compliance to regulatory requirements. The role is highly visible and is strategic and hands on in ongoing fast-moving activities. 

Core Responsibilities:

• 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

• Degree in life sciences, medicine, or pharmacology required (for example, RN, PharmD, or MD)
• 15+ years of industry experience in safety and pharmacovigilance including increasing responsibility in administrative and management roles
• Expertise in safety signal detection and management, clinical safety assessments of individual cases and aggregate data, case processing and routine pharmacovigilance practices, including interactions with Regulatory Authorities
• Expert knowledge and familiarity with FDA regulations, EU GVP and ICH standards for development and marketing of pharmaceutical products, Good Clinical Practice (GCP) requirements, and other applicable regulatory standards
• Experience with vender oversight and management, including budgeting
• Clinical experience strongly preferred
• Proven ability to manage cross-functional collaborations, lead discussions on safety strategy, and resolve complex patient safety concerns.
• Skilled in translating safety data into clear, actionable insights and communicating effectively across internal teams, leadership, and regulatory authorities.
• A “can do” attitude and ability to operate in a fast-paced startup environment

The expected salary range for this position is  $270k - $330k. 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.

Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration