Jobs, fresher vacancy - (Senior) Director Clinical Development • Cambridgeshire

Company: Sobi

Cambridgeshire

Job DescriptionIncluding, but not limited to the following:Shape and develop the clinical development plans, while adhering to the highest scientific and ethical standardsDesign, conduct and report Sobi-sponsored studies in close collaboration with the rest of the clinical development team, the clinical study teams, regulatory, safety and other cross-functional teams, as applicableAct as Study Physician responsible for Sobi-sponsored studies if required: responsible for the development of clinical study synopsis and protocols, contribute to the statistical analysis plans, perform medical monitoring, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriateInteract and consult with key opinion leaders and patient representatives, and lead advisory boards to define the clinical development stratetgy and inform the clinical trial designProvide 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 across multiple geographies.Represent the clinical function in meetings with Health Authorities.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.