• Providing oversight and daily management of all activities pertaining to drug safety within the Praxis pharmacovigilance (PV) department globally. • Leadership and oversight of global PV operations, personnel and strategic resource planning. • Oversight of developing compliant PV procedures and training modules. • Oversight of timely safety reporting to regulatory authorities and external business partners. • Implementation of strategies to manage safety risks. • Ensure the PV department maintains inspection readiness, including representing the company during audits and pharmacovigilance inspections. • Monitor key performance indicators for PV vendors. • Collaborate cross-functionally to ensure timely authoring of key safety deliverables including periodic safety updates and regulatory query responses. • Lead PV/safety aspects of NDA/MAA preparation, including authoring of integrated safety summary and drafting labeling. • Leads capabilities enhancement within PV, including implementation of safety database and data visualization tools for signal detection. • Oversight of relationships with external business partners, including overseeing the alliance, associated requests, and PV agreements, ensuring mechanisms are in place for governance of partnerships.

• Responsible for cross-portfolio support including proactive engagement of select HCPs across multiple specialties • Support pipeline initiatives, enhancing awareness of disease states associated with late-stage pipeline assets • Lead medical education programs, including disease state and product training sessions • Facilitate disease education, including late-stage pipeline disease awareness and clinical trial support • Continuously stay current with the latest medical and scientific advancements relevant to the therapeutic area • Serve as a subject matter expert for internal projects and lead assignments as needed • Collaborate with the Medical Divisional General Manager to develop account plans for emerging KOLs outside of key accounts • Provide targeted education on outcomes data, scientific advances, and other scientific exchange • Respond to HCP Medical Information Requests (MIRs)

• Architecting, implementing, and continually optimizing short- and long-term contract strategies, including sophisticated pricing models. • Serving as the central nexus between legal, finance, sales, and marketing teams to ensure flawless strategic alignment. • Proactively identifying and developing robust avenues for sustained, exponential growth into existing client spaces and successfully capturing new client opportunities within the defense and federal sector.

• Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs. • Develop/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues. • Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate. • Partner with or oversee CROs or Programming vendors to perform the tasks described above. • Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements. • Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives. • Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).