Role Summary
Senior Medical Director within the Hematology program. This individual contributor role will support clinical trials and lead subteams in clinical development. The successful candidate should have prior experience in clinical trials, development programs, health authority interactions, and demonstrated leadership capabilities.
Responsibilities
- Serves as the Clinical Development Lead on subteams including for Marketing Authorization Applications.
- Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring.
- Lead peer-to-peer interactions with investigators.
- Serve as the point of contact for clinical issues between the study team and investigators.
- Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team.
- Provide strategic guidance, clinical insights and interpretation.
- Collaborates with the Global Development Team to create and refine development strategies.
- Represents the company in external engagements or as committee members in joint collaborations.
- Supports regulatory interactions.
- Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.
- Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.
Qualifications
- Required: Medical degree with 5+ years clinical/industry experience.
- Required: Hematology/Oncology clinical experience in academia/industry.
- Required: Late-stage clinical development experience.
- Required: Experience overseeing and providing clinical development leadership across several study teams.
- Required: Excellent communication skills to present complex technical concepts to colleagues from all disciplines and levels.
- Required: Strong strategic and analytical skills.
- Preferred: Leadership or management experience.
- Preferred: Board certified/eligible in hematology/oncology.
- Preferred: Experience across multiple phases of clinical development and across drug classes in oncology.
- Preferred: Late clinical development experience in hematology.
Skills
- Clinical development leadership and study-team coordination.
- Medical knowledge in hematology/oncology and regulatory documentation development.
- Stakeholder communication and collaboration across cross-functional teams.
- Ability to review and interpret clinical data and communicate findings to internal and external stakeholders.
- Stays current with guidelines and literature to inform development plans.
Additional Requirements
- Relocation assistance may be available.
- Work Location: Hybrid role requiring you to live within commuting distance and to work on-site an average of 2.5 days per week.