Medical Director / Senior Medical Director, Oncology Clinical Development (Early Stage)
About the role
The Medical Director / Senior Medical Director, Oncology Clinical Development will serve as Study Responsible Physician for one or more clinical ELVN-001 studies run within the early development team. They will provide medical oversight, lead medical monitoring activities, and contribute to the clinical development strategy for ELVN-001.
Responsibilities
- Serve as Study Responsible Physician and provide medical oversight for one or more clinical studies supporting 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 early-phase oncology clinical trials.
- Lead ongoing medical monitoring activities, including safety review, dose-escalation and dose-expansion assessment, data interpretation, and benefit-risk evaluation.
- 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
- 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 clinical development strategy, study design, 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 hematology/oncology clinical development experience required; Senior Medical Director: 5-8+ years.
- Experience conducting phase 1/2 studies; able to run a clinical trial focused on safety/proof-of concept with minimal supervision.
- Experience in hematologic malignancies and/or targeted oncology therapies strongly preferred.
- 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.
- 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 collaboration skills
- Experience with clinical trial design and execution
- Understanding of regulatory requirements and Good Clinical Practice (GCP)
Benefits
Enliven Therapeutics offers 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.