• Ensuring the highest possible quality of input into significant requests for proposals (RFPs) • Development strategy and regulatory issues • Drug class issues • Protocol and indication considerations, including safety • Team education on indication • Interactions with client’s physicians and/or client area indication leaders prior to and during bid defenses • Identifying business opportunities for the PPD clinical research business • Supporting outstanding input into other areas of the PPD clinical research business activities • Pro-active client engagement: peer-to-peer interactions with therapeutic area leaders and senior directors of companies whose portfolio contains drugs of business interest • Strategic alliance development & support • Client governance and advisory boards • Providing therapeutic and developmental expertise to internal teams, including indication specific training for clinical teams • Guidance during clinical trial executions • Investigator Brochure, clinical study report, NDA/MAA clinical packages development, and other regulatory briefing documents authoring and review • Contribute to design and reporting of feasibility studies • Liaise with investigators and KOLs • Mentor and supervise clinical scientists • Participate in multidisciplinary teams and working groups to contribute to innovative initiatives