.Associate Medical Director Clinical ScienceFull-timeSobi Location: United StatesStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:Competitive compensation for your workEmphasis on work/life balanceCollaborative and team-oriented environmentOpportunities for professional growthDiversity and InclusionMaking a positive impact to help ultra-rare disease patients who are in need of life-saving treatmentsRole & FunctionThe Associate Director Clinical Science is responsible for Sobi's clinical development activities and serves as scientific and medical expert on matters relating to the assigned development program including regulatory and drug safety.Key ResponsibilitiesProvide clinical, medical, and strategic input to clinical development plans, while adhering to the highest scientific and ethical standards.Responsible 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 clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable.Act as Study Physician responsible for Sobi-sponsored studies.Member of the Medicine Development Team and of Clinical Study Team(s).Interact and consult with key opinion leaders and lead advisory boards to define the development plan for new products/indications.Responsible for the development of clinical study synopsis and protocols, 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 and reimbursement authorities.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., scientific advice, IND application, marketing authorization