A clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program to provide a powerful new treatment for patients with MASH.
You will contribute to the execution of the Phase 3 clinical development program for a lead MASH program. Key responsibilities include, clinical trial execution, medical monitoring, data analysis and reporting of results for regulatory submissions or scientific presentations and publications
Job Roles
- Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
- Serve as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical/safety data and working closely with external CRO partners
- Support/manage preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjucation Committees, etc.
- Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities and ethics committee/IRBs as required (eg, Protocols, CSRs, Investigator's Brochure, DSURs, clinical briefing documents, components of BLA/MAA submissions)
- Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (eg, slide presentations, posters and publications)
- Develop professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities
Qualifications
- Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience
- Experience in hepatology, MASH or internal medicine preferred
- At least 3+ years of relevant experience in clinical development in the biopharmaceutical industry
- Direct experience of Phase 3 clinical trial execution and medical monitoring
- Experience with preparation of documentation for BLA/NDA/MAA submissions desirable
- Knowledge of the regulatory path across the various health authorities desirable
- Experience in multiple therapeutic areas, with prior experience in Hepatology, Gastrointestinal, Endocrinology or related field, preferred.
This is a well placed biotech with excellent funding and a broad pipeline of which there lead MASH program is highly thought of. They are looking for a hands on clinical developer to drive this program forward.
An excellent salary, benefits bonus and stock participation scheme is on offer.