Serves as the Medical Monitor (MM) for clinical trials, to address patient eligibility and treatment questions in cooperation with study investigators. Review’s safety data for routine medical data review, trend review, and safety signals from ongoing trials. Reviews serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with investigators to review causality and develop reports (including narratives and analyses of similar events) for reportable SAEs. Participates in the interpretation of data analyses of clinical trial results and developing clinical trial reports. Provides strategic and design input for clinical trials and clinical development plans. Provides input/review of clinical documents, e.g., protocols, investigator’s brochures, case report form design. Participates in site/investigator identification and evaluation for clinical trials, conducts site engagement calls, and visits. Leads preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.) Serves as program medical expert for internal and external collaborators, investigators, consultants, and contract resources Represents the company at scientific meetings and presentations Contributes to scientific affairs by authoring and/or reviewing abstracts, presentations, and manuscripts for medical accuracy and content Attends and provides medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards) Develops and manage relationships with key opinion leaders for clinical programs Independently maintains the state of the art knowledge in the therapeutic area

. Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts. • Owns the sponsor relationship and is responsible for sponsor communication. • Optimizes processes for projections including cost, enrollment and Investigational Product forecasting. • Implements standardized project plans and planning processes. • Implements an efficient contracting and vendor selection process. • Establishes efficient vendor management processes. • Establishes standardized metrics and optimal reporting formats. • Develops and maintains SOPs and work practices applicable to a global organization. • Periodically reviews processes across clinical trial projects to ensure compliance and consistency. • Provides a central point of study contact and single point of escalation on behalf of the functional teams (clinical, data management, biostatistics, medical writing, logistics, contracts, finance, medical, and pharmacovigilance Proactively communicates with the sponsor and internal groups ensuring that they have all the information required on project progress and status (risk analyses, what-if scenarios, contingency plans, technical information, significant changes of any kind, etc.). • Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner. • Lead regular meetings/calls with sponsors to ensure they are fully informed of project progress, proactive decisions/solutions, and how the project objectives are being achieved. • Communicate fiscal, contractual, resource, deliverable and sponsor-related issues to management as appropriate. • Lead the project such that it is completed within budget, schedule and according to contract specifications. • Ensure the project is progressing according to quality standards, SOPs, ICH-GCP, and/or other guidelines to fulfill local regulations.