Clinical Development is composed of a “hands-on” group of dedicated professionals. Team members work flexibly and collaboratively together in a matrix environment, with a high degree of personal accountability for the success of novel and aggressive clinical programs and timelines.
This physician’s primary responsibility will be to advance the company’s immune-oncology program. In addition, this physician will help advance early stage compounds into the clinic.
Key responsibilities for the Medical Director/Senior Medical Director include:
- Accountability for the strategic planning and execution (including study design, method selection, etc) of Phase I through IV global clinical trials
- Analyze and interpret data expertly, and clearly communicate results both internally and externally.
- Oversee ongoing medical monitoring of clinical trials.
- Contributing to, reviewing, and approving clinical regulatory documents (clinical study reports, regulatory submission sections, investigator’s brochures, etc.)
- Working collaboratively with Medical Directors, Biostatistics and Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs.
- Working with US and EU regulators.
- Mentoring junior team members, and providing guidance and opportunity for their professional development.
Minimum Education & Experience Requirements:
- MD with expertise in Oncology
- A minimum of three years’ experience working in biopharma clinical development
- A total of at least six years working in clinical research or clinical development, either in biopharma or academia.
- Direct experience interacting with regulatory authorities.