• Lead or co-lead one or more complex clinical trial(s) in a therapeutic area for one or more compounds • Works closely with Medical Director and Medical Program Lead (as warranted) • Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP) • Authors components with Medical Director and reviewer of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s) • Contributes in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities) • Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis • Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction • Prepare charters and coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, and Safety Committees) • Participate in the development and review of study plans and serve as a liaison to project teams and CROs • Provide input for the development of publications in coordination with Scientific Communications • Perform training at Investigator meetings, CRO/CRA training, SIVs as warranted • Provide mentoring to junior level Clinical Research Scientists