Consultant SVP Clinical Development Fibrosis

h3Consultant SVP Clinical Development Fibrosis /h3pAlentis Therapeutics AG - Allschwil /ppThe Consultant / Contractor SVP of Clinical Development Fibrosis, reporting to the Chief Medical Officer, will oversee clinical research, medical management, and study execution for the Company’s clinical program for Lixudebart and is a key member of the Research and Development Leadership Team. /ph3Tasks /h3ulliProvide medical and scientific leadership across the strategy, execution, interpretation, and communication of clinical data related to Lixudebart. /liliLeading the strategic development of Lixudebart in cooperation with the CMO and executive LT /liliDriving execution of the Lixudebart clinical programs in partnership with the Head of Clinical Operation and other key line functions eg Regulatory. /liliSupporting the PV ensuring overall safety of Lixudebart and supporting overall program safety reporting in collaboration with Safety colleagues. /liliLeading the medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new any disease areas. /liliAs a medical expert, leading interactions with external and internal stakeholders and decision boards. /liliMay work with Research/ Translational Medical Sciences to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BDL (Business Development Licensing) including target identification and due diligences together with other medical matters, as needed. /liliOversee all clinical development activities for assigned programs and ensure alignment with corporate objectives. /liliServe as a scientific and medical spokesperson for the company when appropriate. /li /ulh3Requirements /h3ulliMD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Nephrology practice experience 4 years. /liliExperience with early and late stage clinical development research, including pivotal trials, in kidney diseases, especially rare kidney disease. /liliRelationship and experience leading or being a critical team member for key regulatory activities, such as end-of-phase trial meetings, INDs, Marketing Authorization, special designations. Especially rare and kidney divisions. /liliLeading clinical program team in a matrix organization. /liliHaving high impact and hands on experience supporting BD, IR and other external activities. /liliStrong and existing relationship with KOLs that can be leveraged by Alentis. /liliSwiss/EU or US Citizen or permanent resident. /liliAs a consultant, the individual is expected to be onsite in Switzerland for 1-2 days every two weeks. The remainder of the work can be performed remotely, providing flexibility while maintaining regular in-person collaboration with the team and key stakeholders. /li /ulh3Contact /h3 #J-18808-Ljbffr