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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.
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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
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
Board Certification In Hematology/Oncology