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