(Senior) Director Clinical Development

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.QualificationsExperience / CompetenciesRequired :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 outstanding and intimate understanding of translating early stage programs into the clinic and further across 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 :Excellent communication skills , capable of representing the company to all audiences both internally and externallyStrategic 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 :Good team-player, able to work effectively in a team setting and interact respectfully with people of different cultural, seniority and functional backgroundsHighly 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 that our PV ESP systems and operations environment is being continuously developed to ensure ongoing compliance and to deliver high quality and cost effective outcomesStrong ability to work independently and to make priorities in order to deliver business critical items in timeDemonstrate the Sobi Values : Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.#J-18808-Ljbffr