Senior Medical Director, Clinical Development - Remote

Overview

The Senior Medical Director, Clinical Development provides an excellent opportunity for a physician with experience in oncology clinical development to work within a rapidly growing company focused on precision medicines for oncology targets.

In Short

• Hands-on involvement in clinical studies supporting regulatory approvals.
• Clinical lead for clinical trials, including review of molecular pathology reports.
• Provide clinical expertise and write key documents for studies.
• Lead investigator meetings and networking opportunities.
• Medical review and assessment of clinical data.
• Work closely with Regulatory Affairs for timely filing of documents.
• Provide Pharmacovigilance support for clinical trials.
• Ensure compliance with ethical standards and regulations.
• Serve as the clinical face of the company.
• Support audit and inspection readiness activities.

Requirements

• An M.D. or M.D/Ph.D. with oncology experience required.
• 4+ years in biotechnology or pharmaceutical industry.
• Understanding of drug development from IND through NDA.
• Experience in clinical research and trial design.
• Experience with first-in-human studies is highly desired.
• Experience presenting to various audiences.
• Interaction with Regulatory Authorities preferred.
• Ability to travel approximately 10% domestically and internationally.

Benefits

• Equal employment opportunities.
• Work in a fast-paced, results-driven environment.
• Opportunity to make a clear impact.