Senior Medical Director, Early-Stage Clinical Development

Opportunity

We are seeking an experienced clinical science drug developer to serve as Senior Medical Director of Clinical Development in support of Revolution Medicines’ molecule(s) in clinical or late pre-clinical development. In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s).

Required Skills, Experience and Education

• MD (oncology training preferred) with 7+ years of experience in clinical development in the pharmaceutical/biotech industry and/or academic/other clinical trial setting; some experience in and understanding of early phase drug development preferred.
• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.
• Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally.
• In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills).
• Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required.
• Prominent ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP.
• Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP.
• Proven ability to drive various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements.
• Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions.
• Proven ability to lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.
• Proven ability to lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.
• Proven ability to manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.
• Stays abreast of the latest scientific advancements and regulatory trends in the field of clinical development.
• Potential to manage multiple direct reports.