Medical Director / Senior Medical Director, Oncology Clinical Development (Late Stage)
Enliven Therapeutics
August 18, 2026
Remote
United States
Clinical Research and Development
Role Summary
Senior Director / Medical Director, Clinical Development (Late Stage) providing clinical development leadership for late-stage development of ELVN-001. Serves as Study Responsible Physician for one or more Phase 3 hematology/oncology studies; leads trial execution, medical oversight, safety review, data interpretation, and clinical strategy.
Key Responsibilities
- Lead execution of pivotal clinical trials.
- Provide medical oversight for one or more Phase 3 studies; serve as Study Responsible Physician.
- Mentor and oversee clinical scientists.
- Partner cross-functionally (Clinical Ops, Biostatistics, Clinical Pharmacology, Regulatory, Translational Sciences, Data Management, etc.) to ensure high-quality, timely execution.
- Contribute to design, conduct, analysis, and interpretation of late-stage oncology trials.
- Lead medical monitoring: safety review, data interpretation, benefit-risk evaluation, protocol deviation review, endpoint adjudication.
- Collaborate on clinical documents (protocols, amendments, IBs, informed consent forms, CSRs), medical data review, and clinical presentations/publications.
- Support regulatory submissions and responses to Health Authority/Ethics Committee inquiries.
- Build relationships with investigators, cooperative groups, and KOLs.
Requirements
- MD or equivalent; board certification/eligibility in Hematology/Oncology preferred.
- Medical Director: 3+ years oncology clinical development; Senior Medical Director: 5–8+ years with demonstrated study leadership.
- Strong understanding of trial design, medical monitoring, safety review, data interpretation, regulatory expectations, and GCP.
- Experience with registrational/pivotal studies, Health Authority interactions, NDA/BLA preparation, and global development strategy.
- Experience with key clinical/regulatory documents (protocols, amendments, IBs, CSRs, IND/NDA materials, briefing documents).
- Strong leadership, communication, collaboration; hands-on ability in fast-paced biotech.
- Travel up to ~30%; occasional off-hours/on-call as needed.
Benefits/Compensation
- Full-time remote (40 hours/week). Benefits included; bonus/equity may be provided.
- Salary range: $260k–$305k (Medical Director); $290k–$350k (Sr. Director).
Senior Director / Medical Director, Clinical Development (Late Stage) providing clinical development leadership for late-stage development of ELVN-001. Serves as Study Responsible Physician for one or more Phase 3 hematology/oncology studies; leads trial execution, medical oversight, safety review, data interpretation, and clinical strategy.
Key Responsibilities
- Lead execution of pivotal clinical trials.
- Provide medical oversight for one or more Phase 3 studies; serve as Study Responsible Physician.
- Mentor and oversee clinical scientists.
- Partner cross-functionally (Clinical Ops, Biostatistics, Clinical Pharmacology, Regulatory, Translational Sciences, Data Management, etc.) to ensure high-quality, timely execution.
- Contribute to design, conduct, analysis, and interpretation of late-stage oncology trials.
- Lead medical monitoring: safety review, data interpretation, benefit-risk evaluation, protocol deviation review, endpoint adjudication.
- Collaborate on clinical documents (protocols, amendments, IBs, informed consent forms, CSRs), medical data review, and clinical presentations/publications.
- Support regulatory submissions and responses to Health Authority/Ethics Committee inquiries.
- Build relationships with investigators, cooperative groups, and KOLs.
Requirements
- MD or equivalent; board certification/eligibility in Hematology/Oncology preferred.
- Medical Director: 3+ years oncology clinical development; Senior Medical Director: 5–8+ years with demonstrated study leadership.
- Strong understanding of trial design, medical monitoring, safety review, data interpretation, regulatory expectations, and GCP.
- Experience with registrational/pivotal studies, Health Authority interactions, NDA/BLA preparation, and global development strategy.
- Experience with key clinical/regulatory documents (protocols, amendments, IBs, CSRs, IND/NDA materials, briefing documents).
- Strong leadership, communication, collaboration; hands-on ability in fast-paced biotech.
- Travel up to ~30%; occasional off-hours/on-call as needed.
Benefits/Compensation
- Full-time remote (40 hours/week). Benefits included; bonus/equity may be provided.
- Salary range: $260k–$305k (Medical Director); $290k–$350k (Sr. Director).