We are seeking a physician to serve as a Senior Medical Director to oversee global Phase 3 clinical trials and BLA (Biologic Licensing Application) filings.
The incumbent will be primarily responsible for developing and executing an integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies.
They will be responsible for obtaining scientific advisory input, work with biostatisticians for phase 3 design and analyses, support regulatory interactions for product advancement, and work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence.
This position will provide medical insight across a myriad of functions from discovery to manufacturing are expected.
Additionally, the Medical Director will play a pivotal role in leading investigator engagements including travel to support face-to-face interaction and protocol training.
Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in an extremely fast-paced and intense environment.
The Medical Director will serve as a leader on one multiple potentially pivotal programs.
Requirements
Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development
Minimum of 5+ years’ experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology
Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA
Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission.
Benefits
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
This may be different in other locations due to differences in the cost of labor.
The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.