Senior Director, Clinical Development (exclusive)

Senior Director, Clinical Development (exclusive)

My client (a growing publicly traded commercial biopharma company) is seeking an experienced Sr. Director, Clinical Development to provide medical leadership across multiple lymphoma programs (both early and late stage). The individual will report into a VP and will need to be on-site (NJ) 1 - 2 days a month.

Responsibilities:

• Provide medical leadership for assigned clinical trials/programs (phase I - III).
• Develop protocols/amendments, provide medical monitoring of study conduct and oversight of patient safety, and provide medical support for data analysis/trial reporting.
• Point of contact for internal management, investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions.
• Work with US and European teams to development clinical strategies, clinical development plans, and define regulatory strategy.

Requirements:

• MD
• Experience with lymphoma studies
• Board Certified/Board Eligible Hematologist/Oncologist (a plus)
• 8+ of experience in Clinical Development in industry and academia designing and overseeing clinical trials in lymphoma / oncology / hematology.
• Strong knowledge of preclinical oncology research methodology to enable interpretation of preclinical data for devising clinical hypotheses and clinical planning purposes.
• Experience preparing INDs, CTAs, BLAs, NDAs