Medical Director / Senior Medical Director, Oncology Clinical Development (Late Stage)

About the role

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. We aim to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being.

Responsibilities

• Lead execution of pivotal clinical trials
• Serve as Study Responsible Physician and provide medical oversight for one or more Phase 3 clinical studies supporting the late-stage development of ELVN-001.
• Provide leadership, mentoring, and oversight to clinical scientists across assigned studies and development activities.
• Partner cross-functionally with Clinical Operations, Biostatistics, Clinical Pharmacology, Regulatory Affairs, Translational Sciences, Data Management, and other functions to ensure high-quality and timely study execution.
• Contribute to the design, conduct, analysis, and interpretation of late-stage oncology clinical trials.
• Lead ongoing medical monitoring activities, including safety review, data interpretation, benefit-risk evaluation, protocol deviation review, and endpoint adjudication.
• Collaborate with clinical scientists and cross-functional partners on:
• Preparation and review of clinical study documents, including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports
• Medical review of clinical data and support of data review activities
• Preparation and presentation of clinical data for internal governance meetings, investigator meetings, scientific congresses, and external stakeholder interactions
• Development of study-related training materials and investigator communications
• Support regulatory submissions and responses to Health Authority and Ethics Committee inquiries
• Build and maintain relationships with clinical investigators, cooperative groups, and Key Opinion Leaders.
• Contribute to registrational clinical development strategy, Phase 3 execution, commercialization planning and lifecycle planning for oncology programs.
• Participate in preparation of scientific publications, abstracts, and presentations.
• Review and synthesize relevant scientific and medical literature to support program strategy and competitive awareness.
• Support broader clinical development and medical affairs initiatives as needed.

Requirements

• MD or equivalent medical degree required; board certification or eligibility in Hematology/Oncology or related specialty preferred.
• Medical Director: 3+ years of oncology clinical development experience required; Senior Medical Director 5-8+ years with demonstrated study leadership.
• Experience in hematologic malignancies and/or targeted oncology therapies strongly preferred.
• Experience with registrational studies, pivotal trial execution, Health Authority interactions, NDA/BLA preparation, and global development strategy.
• Strong understanding of clinical trial design, medical monitoring, safety review, data interpretation, regulatory expectations, and GCP.
• Experience contributing to key clinical and regulatory documents, including protocols, amendments, IBs, CSRs, IND/NDA materials, and briefing documents.
• Strong scientific and clinical judgment, with the ability to interpret complex data and communicate clearly across medical and cross-functional audiences.
• Demonstrated ability to work effectively with cross-functional teams, external investigators, CROs, and vendors.
• Excellent leadership, collaboration, communication, and presentation skills.
• Comfortable operating in a fast-paced biotech environment requiring both strategic thinking and hands-on execution.
• High degree of ownership, flexibility, urgency, attention to detail, and commitment to patient safety and scientific integrity.
• Late-stage: Experience with registrational studies, pivotal trial execution, NDA/BLA preparation, Health Authority interactions, and/or global development strategy preferred.
• Ability to travel up to 30% for key scientific conferences and to essential in-person company meetings.

Qualifications

• MD or equivalent medical degree required.
• Board certification or eligibility in Hematology/Oncology or related specialty preferred.
• 3+ years of oncology clinical development experience required; 5-8+ years with demonstrated study leadership for Senior Medical Director.
• Experience in hematologic malignancies and/or targeted oncology therapies preferred.
• Experience with registrational studies, pivotal trial execution, Health Authority interactions, NDA/BLA preparation, and global development strategy.
• Strong understanding of clinical trial design, medical monitoring, safety review, data interpretation, regulatory expectations, and GCP.
• Experience contributing to key clinical and regulatory documents, including protocols, amendments, IBs, CSRs, IND/NDA materials, and briefing documents.
• Strong scientific and clinical judgment, with the ability to interpret complex data and communicate clearly across medical and cross-functional audiences.
• Demonstrated ability to work effectively with cross-functional teams, external investigators, CROs, and vendors.
• Excellent leadership, collaboration, communication, and presentation skills.
• Comfortable operating in a fast-paced biotech environment requiring both strategic thinking and hands-on execution.
• High degree of ownership, flexibility, urgency, attention to detail, and commitment to patient safety and scientific integrity.
• Late-stage: Experience with registrational studies, pivotal trial execution, NDA/BLA preparation, Health Authority interactions, and/or global development strategy preferred.
• Ability to travel up to 30% for key scientific conferences and to essential in-person company meetings.

Skills

• Strong scientific and clinical judgment
• Effective communication and presentation skills
• Leadership and mentoring abilities
• Collaborative working style
• Hands-on clinical development experience
• Experience with regulatory submissions and Health Authority interactions
• Experience with clinical trial design and execution
• Experience with data interpretation and safety review
• Experience with cross-functional team coordination

Benefits

Enliven Therapeutics provides a comprehensive benefits package including health insurance, retirement plans, and paid time off.

Pay

The annual salary range Enliven reasonably and in good faith expects to pay for this position at the time of this posting is $260k - $305k. The actual salary offered will be determined based on factors such as experience, qualifications, skills and expertise, geographic location, and other job-related factors permitted by law.

Schedule

This is a full-time remote position (40 hours/week). Occasional evening, weekend, holiday, and on-call work may be required as job duties demand. Travel of around 30% may be expected for this role.