Senior Medical Director, Early-Stage Clinical Development

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.

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.

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).

The scope of activities spans early-stage clinical research and may extend to studies supporting regulatory submissions including Breakthrough-Therapy-Designation (BTD) or Accelerated Approvals (AA).

You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

Lead clinical science and medical aspects of the clinical development strategy and clinical documentation.

Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting.