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Medical Director – Senior Medical Director, Oncology Clinical Development
Enliven TherapeuticsDirector/Senior Medical Director for Oncology Clinical Development focusing on early-stage drug development. Leading clinical trials and contributing to therapeutic strategies at Enliven Therapeutics.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading Phase 3 oncology clinical trials, providing medical oversight, and ensuring compliance with regulatory expectations. Possesses strong scientific judgment and the ability to collaborate effectively with cross-functional teams while maintaining a commitment to patient safety and scientific integrity.
Highest-signal resume keywords
MD Or Equivalent Medical DegreeOncology Clinical Development ExperienceClinical Trial DesignRegulatory SubmissionsLeadership And Collaboration Skills
ATS Keywords
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Hard Skills
Medical MonitoringData InterpretationSafety ReviewClinical Study Document PreparationNDA/BLA PreparationGCP UnderstandingHematologic Malignancies ExperiencePivotal Trial ExecutionClinical Data ReviewScientific Publication Preparation
Soft Skills
LeadershipCollaborationCommunicationPresentation SkillsAttention To Detail
Certifications & Qualifications
Board Certification In Hematology/Oncology
Industry Keywords
Clinical TrialsRegulatory AffairsBiostatisticsTranslational SciencesClinical OperationsHealth Authority InteractionsClinical Development StrategyPatient SafetyScientific IntegrityFast-Paced Biotech Environment
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Benefits are included and other incentives such as bonus and equity may be provided.