(Senior) Director Clinical Development

Overview Including, but not limited to the following :Shape and develop the clinical development plans, while adhering to the highest scientific and ethical standards.Design, conduct and report Sobi-sponsored studies in close collaboration with the clinical development team, clinical study teams, regulatory, safety and other cross-functional teams, as applicable.Interact and consult with key opinion leaders and patient representatives, and lead advisory boards to define the clinical development strategy and inform the clinical trial design.Provide strategic and operational clinical development expertise in interactions with regulatory and reimbursement authorities.Contribute high-quality scientific and medical input to the delivery of clinical parts of submissions and other regulatory documents, as well as to responses to Health Authority questions to support e.g., scientific advice, IND applications, and marketing authorization across multiple geographies.Represent the clinical function in meetings with Health Authorities.ResponsibilitiesDesign, conduct and report Sobi-sponsored studies in close collaboration with the clinical development team, clinical study teams, regulatory, safety and other cross-functional teams, as applicable.Act as Study Physician for Sobi-sponsored studies when required: develop clinical study synopsis and protocols, contribute to 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.Interact with key opinion leaders and patient representatives; lead advisory boards to define clinical development strategy and inform trial design.Provide strategic and operational clinical development expertise in interactions with regulatory and reimbursement authorities.Contribute high-quality medical input to the delivery of clinical parts of submissions and other regulatory documents, and to responses to Health Authority questions to support scientific advice, IND applications, and marketing authorization across multiple geographies.Represent the clinical function in meetings with Health Authorities.Provide scientific and medical expert support to other functions within Sobi on specific therapeutic areas, including global safety, medical affairs activities (advisory boards, scientific communications & publications), and business development (due diligence evaluations of external compounds and M&A), where applicable.QualificationsRequired : Medical DegreeSpecialty in cardiology, lipidology, endocrinology or relevant previous clinical development experience (+7 years) in these therapeutic areasRelevant global clinical development experience in the Pharmaceutical Industry (+10 years)Previous experience in interactions with major Health AuthoritiesSolid record of accomplishment in drug development programs within the relevant therapeutic area, demonstrating understanding of translating early-stage programs into the clinic and further along the clinical development chainExpertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision makingDemonstrated ability to build and execute strategic and tactical development and medical plansExperience and ability to engage with key internal and external stakeholdersHighly Desired : At least 5 years clinical experience in treating patientsSuccessful interactions with major Health Authorities leading to drug approvalsSkills / LanguagesRequired : Medical DegreeStrategic mindsetExcellent organizational skills, be a self-motivated driver of best practices and processes in the management of projects and operationsExcellent written and verbal communication skills in EnglishAble to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.Personal AttributesRequired : Medical DegreeHighly flexible and comfortable working in a fast-paced and quickly changing environmentAble to work well in a virtual environment.Proven self-management by showing initiative, good organization and willingness to be held accountableResults oriented with a can-do and proactive attitudeHigh medical, scientific and ethical integrityAble to prioritizeAdditional InformationDriven, flexible and with strong team working and project management skillsStrong interpersonal, cultural and communication skillsAnalytical, with a problem-solving and collaborative mindsetForward-looking mindset, to ensure ongoing compliance and to deliver high quality and cost-effective outcomesStrong ability to work independently and to set priorities to deliver business-critical items on timeDemonstrate the Sobi Values: Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.Note: The previous identifiers (e.g., J-*****-Ljbffr) and location references have been omitted to focus on core job content.#J-*****-Ljbffr