Contractor SVP Clinical Development Fibrosis (Hepatology)

Alentis Therapeutics, the Claudin-1 Company, is on a mission to treat cancer and reverse fibrosis. To this end, we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney, liver, and lung fibrosis.

Tasks

The SVP of Clinical Development Fibrosis (Hepatology), 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.

• Leading the strategic development of Lixudebart in cooperation with the CMO and executive LT
• Provide medical and scientific leadership across the strategy, execution, interpretation, and communication of clinical data related to Lixudebart.
• Driving execution of the Lixudebart clinical programs in partnership with the Head of Clinical Operation and other key line functions eg Regulatory.
• Supporting the PV ensuring overall safety of Lixudebart and supporting overall program safety reporting in collaboration with Safety colleagues.
• Leading 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.
• Work with Research/ Translational Medical Sciences to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed.
• As a medical expert, leading interactions with external and internal stakeholders and decision boards.
• Serve as a scientific and medical spokesperson for the company when appropriate.

Requirements

• MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Hepatology practice experience 4 years.
• Experience with early and late stage clinical development & research, including pivotal trials, in liver diseases, especially rare liver disease.
• Relationship 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 liver divisions.
• Leading clinical program team in a matrix organization.
• Having high impact and hands on experience supporting BD, IR and other external activities.
• Strong and existing relationship with KOLs that can be leveraged by Alentis.