Medical Director – Senior Medical Director, Oncology Clinical Development

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Enliven Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Enliven Therapeutics is a company dedicated to developing innovative solutions for cancer treatment. They focus on creating small molecule kinase inhibitors designed to improve efficacy, safety, and patient convenience. With programs targeting BCR-ABL, HER2, and additional pathways, Enliven Therapeutics aims to enhance the precision and selectivity of cancer therapeutics, combat resistance, and address brain metastases. The company prides itself on a team of experienced drug developers and aims to help cancer patients live longer and better lives.

📋 Description

• 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. • 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.

🏖️ Benefits

• Benefits are included and other incentives such as bonus and equity may be provided.