• Provide study, project and program-specific medical monitoring and review services • Leading of all medical aspects of contracted tasks • Supervising of safety variables • Discussing with clients, investigators and healthcare professionals of medical issues in the pre and post approval services by using accurate medical judgment, interpretation and decision • Provide medical consultation to team members and answer study related medical questions • Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately • Analysis and assessment of safety data to identify and run emerging safety signals • Medical review of individual case safety reports, serious adverse event reports and clinical outcome reports. • Assist in Business Development activities • Present PPD standard medical safety processes to clients at business development meetings and connect with various medical communities to explore and expand PPD business • Participate in training of project teams • Provide therapeutic and protocol training as needed • Write, review and approve reports, regulatory submissions and protocols, ensuring that the medical content is accurate and complete.

• Provide medical oversight, expertise and leadership to ensure the delivery of cost effective, quality healthcare services to health plan members • Serves as clinical advisor to and educator of medical management staff making sure correct clinical judgment is applied to all medical management determinations • Provide leadership and expertise in the development, implementation and interpretation of medical review and quality related policies and guidelines • Provide oversight and direction for staff and provider training and education • Promote positive relations with the local medical community, including periodic consultation with providers or prescribers • Review case management data, identifies trends and gaps in care and recommends corrective actions • Review all quality of care issues and oversees the development and implementation of processes for improvement • Monitor performance indicators to ensure the delivery of cost-effective care within quality standards • Monitor member and provider satisfaction and recommends and implements changes to improve satisfaction levels • Work collaboratively to develop corporate clinical care standards and medical practice policies • Provide medical guidance to the Medical Management department

• Lead the design and implementation of clinical development programs • Oversee education of investigators and study personnel • Lead clinical study teams and monitor overall study integrity • Present at scientific and regulatory meetings globally • Develop relationships with academic investigators • Author clinical sections for regulatory filings • Maintain knowledge of compliance and regulatory requirements • Participate in business development activities as required

• Provide clinical, scientific, and strategic input to clinical development plans and activities, while adhering to the highest scientific and ethical standards ensuring for success. • Act as Medical Director responsible for Sobi-sponsored studies. • Responsibility for planning, designing, conducting (including medical monitoring) and reporting Sobi-sponsored studies, in close collaboration with the Medical Development Lead (MDL), Medical Program Lead (MPL) and other core members of the development team, clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable. • Member of the Medical Development Team and of Clinical Study Team(s) and collaborate with the Medical Development Lead for scientific and medical development strategy. • Interact and consult with key opinion leaders and lead advisory boards to define the development plan for new products/indications. • Responsible for development of clinical study protocols and reports and contribute to the statistical analysis plans, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriate • Provide strategic and operational clinical development expertise in interactions with regulatory authorities for assigned products/projects, as requested and appropriate. • Contribute with high-quality scientific and medical input to delivery of clinical parts of submissions and other regulatory documents as well as to responses to Health Authority’s questions to support e.g., briefing documents, scientific advice, BLA/MAA applications. • Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on specific therapeutic area of expertise, including global safety, medical affairs activities such as advisory boards, scientific communications & publications, and business development such as due diligence evaluations of external compounds and M&A.