Medical Director – Senior Medical Director, Oncology Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Drive the execution of essential clinical trials.

• Act as the Study Responsible Physician, offering medical oversight for one or more Phase 3 clinical studies related to the late-stage development of ELVN-001.

• Provide leadership, mentoring, and guidance to clinical scientists involved in assigned studies and development activities.

• Collaborate cross-functionally with Clinical Operations, Biostatistics, Clinical Pharmacology, Regulatory Affairs, Translational Sciences, Data Management, and other departments to ensure effective and timely study execution.

• Contribute to the design, conduct, analysis, and interpretation of late-stage oncology clinical trials.

• Oversee ongoing medical monitoring tasks, including safety evaluations, data interpretation, benefit-risk assessments, protocol deviation evaluations, and endpoint adjudication.

• Work alongside clinical scientists and cross-functional partners on:

• The preparation and review of clinical study documents, such as protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.

• The medical review of clinical data and support for data review activities.

• The preparation and presentation of clinical data for internal governance meetings, investigator meetings, scientific congresses, and external stakeholder engagements.

• The development of study-related training materials and communications for investigators.

• Supporting regulatory submissions and addressing inquiries from Health Authorities and Ethics Committees.

• Establishing and nurturing relationships with clinical investigators, cooperative groups, and Key Opinion Leaders.

• Contributing to the registrational clinical development strategy, executing Phase 3 trials, and planning for commercialization and lifecycle management of oncology programs.

• Participating in the preparation of scientific publications, abstracts, and presentations.

• Reviewing and synthesizing relevant scientific and medical literature to support program strategy and maintain competitive awareness.

• Assisting with broader clinical development and medical affairs initiatives as necessary.

⛳️ Requirements

• An MD or equivalent medical degree is required; board certification or eligibility in Hematology/Oncology or a related specialty is preferred.

• For Medical Director: A minimum of 3 years of oncology clinical development experience is required; for Senior Medical Director: 5-8+ years with proven study leadership experience.

• Experience in hematologic malignancies and/or targeted oncology therapies is strongly preferred.

• Familiarity with registrational studies, pivotal trial execution, Health Authority interactions, NDA/BLA preparation, and global development strategies is essential.

• A strong understanding of clinical trial design, medical monitoring, safety review, data interpretation, regulatory expectations, and GCP is required.

• Experience in contributing to key clinical and regulatory documents, including protocols, amendments, IBs, CSRs, IND/NDA materials, and briefing documents is needed.

• Strong scientific and clinical judgment, capable of interpreting complex data and communicating effectively with medical and cross-functional teams.

• Proven ability to work successfully with cross-functional teams, external investigators, CROs, and vendors.

• Exceptional leadership, collaboration, communication, and presentation skills.

• Comfortable working in a dynamic biotech environment that demands both strategic thinking and hands-on execution.

• A high level of ownership, flexibility, urgency, attention to detail, and a commitment to patient safety and scientific integrity is expected.

• Willingness to travel up to 30% for key scientific conferences and essential in-person company meetings.

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

🏝️ Benefits

• Benefits are provided along with additional incentives such as bonuses and equity options.