(Senior) Director Clinical Development

Company DescriptionThe (Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product.Specific responsibilities include design of clinical trials (any phase as required by the clinical development program, including phase IV), clinical protocol development, medical monitoring of clinical trials, analysis of study data, contribution and review of clinical study reports, of clinical modules of registration dossiers, of briefing books for interactions with Health Authorities.The (senior) Director Clinical Development will represent and defend the clinical strategy during the MAA regulatory review process across multiple geographies and in meetings with Health Authorities.The individual will closely work with other RD functions to ensure the successful progress of projects and clinical trials and will interact with the scientific and patient community to ensure their insights are adequately incorporated in the clinical trials.This position will require representing Sobi clinical development strategy externally as well as in internal meetings with senior management if required.Essential to success is a strong clinical development background with previous experience in late stage clinical trial design and conduct and in major regulatory submission (e.G. EU, Canada, Japan); excellent medicalknowledge in lipidology and cardiovascular, ability to build and maintain strong relationships with study investigators / key opinion leaders (KOLs), and ability to collaborate crossfunctionally.Job DescriptionShape 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 strategy and inform the clinical trial designProvide strategic and operational clinical development expertise in interactions with regulatory and reimbursement authoritiesContribute 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 geographiesRepresent the clinical function in meetings with Health AuthoritiesWhere 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/Competencies (Required)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 stakeholdersExperience/Competencies (Highly Desired)At least 5 years clinical experience in treating patientsSuccessful interactions with major Health Authorities leading to drug approvalsSkills/LanguagesRequiredExcellent 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 PartnershipPersonal Attributes (Required)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 PartnershipSeniority levelDirectorEmployment typeFull-timeJob functionScienceIndustriesPharmaceutical Manufacturing#J-*****-Ljbffr