Director/Sr. Director/Executive Director, Clinical Regulatory Affairs

SystImmune is a leading clinical-stage biopharmaceutical company developing innovative cancer treatments. The Director/Sr. Director/Executive Director of Clinical Regulatory Affairs will drive regulatory strategy and execution within project development teams and the RA Department. The role will focus on global regulatory aspects of preclinical and clinical areas of Oncology drug development.

Requirements

• Ph.D. or advanced degree
• 5+ years of pharmaceutical industry experience in novel biologic/ADC based oncology drug development
• 3+ years of global regulatory strategy experience
• Solution centric mindset and ability to thrive in a fast-paced small company environment
• Prior experience working in cross-company joint development collaboration settings
• Deep understanding of US FDA, ICH, and international pharmaceutical guidance, regulations, and industry standard practices

Benefits

• 100% paid employee premiums for medical/dental/vision
• STD, LTD
• 401(k) plan with 50% company match of up to 3%
• Vesting schedule of 5 years
• 15 PTO days per year
• Sick leave
• 11 paid holidays