Senior Medical Director, Safety and Pharmacovigilance

Enliven Therapeutics, Inc.; Maryland; Remote; USD 290,000 - 340,000; Full time

Job summary

Enliven Therapeutics seeks a Senior Medical Director, Safety and Pharmacovigilance. The role involves overseeing safety strategy across clinical programs. The ideal candidate will have extensive drug development experience, particularly in oncology, and demonstrate strong leadership and analytical skills to ensure patient safety. This position is fully remote, targeting candidates in the US, aligned to Pacific Time hours.

Qualifications

• 5+ years of drug development experience with 3+ years as a safety medical monitor.
• Experience in oncology and/or hematologic therapeutic areas.
• Understanding of pharmacovigilance data and ability to interpret findings.

Responsibilities

• Oversee safety strategy and medical reviews for clinical programs.
• Collaborate cross-functionally on safety monitoring and compliance.
• Manage relationships with regulatory authorities as a subject matter expert.

Skills

Leadership

Communication

Analytical skills

Collaboration

Adaptability

Education

MD/DO Degree

Job description

All Jobs > Senior Medical Director, Safety and Pharmacovigilance

Senior Medical Director, Safety and Pharmacovigilance
Fully Remote • Remote • Clinical Development and Pharmacovigilance

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 senior medical safety physician who will serve as the Safety lead for key clinical programs and implement an overall medical safety strategy across the pipeline. The successful candidate will be a hands-on doer with responsibility for scientific and clinical safety content across the pipeline, overseeing safety strategy for assigned programs, providing safety input on clinical protocols, informed consent, investigator brochures, and regulatory submissions. The candidate will perform the medical reviews and oversight of process for all types of safety events, including analysis of similar events, company causality assessments, and expectedness assessment, review of MedDRA coding, signal detection, risk management and pharmacovigilance oversight. The Senior Physician will represent Drug Safety/PV on cross-functional teams and serve as a subject matter expert for safety data interpretation, signal detection, and risk mitigation. The role is highly collaboration focused and will need to integrate with safety operations, regulatory, quality and other technical operations stakeholders. Strong communication is required to relay impact of “go/no go” decisions or modification of development plan or study design, including potential impact on timeline or product labeling, ensuring the priority of patient safety.

The position reports to the Chief Medical Officer and is a remote position. The candidate should be based in the US and primarily work Pacific Time hours. The ideal candidate will have performed a similar role at a smaller biotech company in oncology and/or hematology and have Phase 3 trial and small molecule experience.

Role Scope

• Oversee an external safety vendor while also performing the medical reviews and oversight of process for all types of safety events, including analysis of similar events, company causality assessments, and expectedness assessment, review of MedDRA coding, signal detection, risk management and pharmacovigilance oversight.
• Lead safety surveillance and support benefit-risk oversight for assigned compounds, serving as the primary point of accountability for case processing and safety data review.
• Collaborate cross-functionally to embed pharmacovigilance principles into clinical development, ensuring proactive safety monitoring plans and operational alignment with evolving patient safety needs
• Contribute pharmacovigilance expertise to the Clinical Development Plan, Safety Management Plan, and protocol development for early-phase and Phase 3 studies
• Support development of Risk Management Plans and other functional leads, ensuring compliance with regulatory expectations and a patient-centric approach to risk mitigation
• Contribute to and review global safety documents, including DSURs, PBRERs, and ad hoc safety reports, with a clear focus on data integrity and regulatory readiness
• Ensure regulatory compliance through active participation in audits, inspections, and continuous evaluation of internal processes aligned with global pharmacovigilance requirements
• Communicate critical safety issues swiftly and decisively, providing PV leadership with detailed analyses and strategic recommendations for issue management and resolution
• Represent clinical safety interests externally, engaging with Health Authorities, external safety boards, and internal governance bodies as the pharmacovigilance subject matter expert
• Collaborate with clinical and other partners in overall development and company strategy

Requirements

• MD/DO degree with 5+ years of drug development experience, with 3+ years acting as a safety medical monitor in industry
• Demonstrated expertise in medical evaluation and safety surveillance, ideally in oncology and/or hematologic therapeutic areas
• Understanding of pharmacovigilance data, with the ability to interpret and act on complex findings.
• Well-versed in global drug safety regulatory frameworks, including ICH guidelines, 21 CFR, and EU GVP requirements for investigational products
• Hands-on experience with safety data analysis, MedDRA coding, and adherence to international PV standards and practices.
• Highly organized and adaptable, with strong written and verbal communication skills, and the ability to operate effectively in a fast-paced, evolving environment.
• 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 $290k - $340k. 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.

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.

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