Job Description Director level MD with 2-5 years of experience within a pharmaceutical company environment required - Authorized to work in the USA and ability to travel internationally Design study protocols, clinical development plans for oncology or autoimmune therapeutic areas Ability to author key clinical sections of CSR, IB, IND sections, regulatory briefing books, Annual Reports, CSR Ability to prepare strategy, present to senior management, internal and external KOL's Create and/or review study documents/plans including monitoring plan, data management plan, safety review plan, etc. Performing ongoing data reviews Communicate internally and externally on clinical trial design/ results Identify clinical development risks and propose risk mitigation plans Supervise project team Serve as medical monitor Select and train clinical research centers and investigators Oversees planning and management of investigator meetings, advisory boards and other scientific committees Participate in the selection of sites, CROs, and vendors