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

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

Status: Full Time; Exempt

Location: Remote USA

About Us

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.

Our discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs. By combining clinically validated targets and specific target product profiles with disciplined clinical trial design and regulatory strategy, we aim to develop drugs that address unmet needs with an increased probability of clinical and commercial success.

About ELVN-001

ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the breakpoint cluster region – Abelson (“BCR-ABL”) gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (“CML”). It targets the ATP-binding site of the ABL1 kinase domain and binds to a unique P-loop “folded-in” active conformation of ABL1, creating a narrow selectivity tunnel. 

As a highly selective ATP-competitive inhibitor, ELVN-001 is differentiated from other ATP-competitive inhibitors in that it avoids off-target activity that may cause adverse events. With this potential additional safety margin, ELVN-001 may be optimally dosed to drive better efficacy. Additionally, ELVN-001 potentially represents a complementary option to allosteric BCR-ABL inhibitors (e.g., asciminib) due to its distinct mechanism of action and high selectivity which may play an increasingly important role in the standard of care for CML. Specifically, ELVN-001 was designed to have activity against emerging mutations known to confer resistance to allosteric TKIs, including asciminib. ELVN-001 was also designed to be a more attractive option for patients with comorbidities, on concomitant medications or desiring more freedom from stringent administration requirements. 

ELVN-001 is currently being evaluated in the Phase 1 ENABLE clinical trial in heavily pretreated patients with CML, and we plan to initiate ENABLE-2, a 2L+ Phase 3 pivotal trial in the second half of 2026. The most recent data is available on the Program Presentation & Publications section of the website. 

Role Summary

Enliven Therapeutics is seeking a highly motivated Senior Director / Medical Director, Clinical Development to provide clinical development leadership for the late-stage development of ELVN-001. This individual will serve as Study Responsible Physician for one or more Phase 3 hematology/oncology studies and play a key role in trial execution, medical oversight, safety review, data interpretation, and clinical strategy.

This is a highly cross-functional and hands-on role suited for a physician with strong oncology clinical development experience, sound medical judgment, and the ability to operate effectively in a fast-paced, small-company environment. The ideal candidate will bring experience supporting late-stage oncology trials, including pivotal or registrational studies, Health Authority interactions, and collaboration with cross-functional teams and external investigators.

Key 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.

• 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. 
• Must possess excellent oral and written English communication skills.

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.

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. Benefits are included and other incentives such as bonus and equity may be provided. This range is subject to change based on business needs, job scope changes, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. 

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.