International Medical Director

Role Overview

• Be part of early to late-stage clinical development and the critical discussions/decisions that will pave the way for the clinical development program for different compounds with diverse mechanism of action in the therapeutic area of Liver diseases
• Support the clinical development program(s) as medical lead and expert drug developer, providing input and guidance to both internal and external stakeholders
• Work with the Global Project Team to deliver strategic clinical development support for the Liver programs, including plans for potential expansion into adjacent indications
• Provide clinical and scientific expertise to the design of studies, writing of protocols and other study and regulatory-related documents
• Participate in the analysis and interpretation of data, ensure integrity of trial data, and assist in reporting of study results including preparation of scientific summaries, abstracts and manuscripts
• Provide leadership in the execution of clinical trials including medical oversight during trial conduct
• Give oral presentations internally and externally and co-author publications
• Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements
• Work with Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, Product Supply and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to emerging clinical-stage programs
• Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems
• Interface with regulatory authorities as appropriate in support of the development objectives for the project, and assist regulatory colleagues in the compilation of submissions, meeting packages, and responses to inquiries

Requirements

• MD or the international equivalent is required
• board certified hepatologist or clinical experience in hepatology preferred
• Strong scientific background with experience in reviewing & interpreting scientific and/or study data is required
• Track record of scientific publications strongly preferred
• 1+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research background
• Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable
• Team player who works collaboratively in a challenging team matrix environment
• Ability to work independently to resolve challenges and conflicts
• Excellent written and oral communication skills
• Integrity, honesty and highest ethical standards and a sense of personal accountability
• Quickly adapt and provide innovative solutions to challenges as they present themselves

Tech Stack

• Google Cloud Platform

Benefits

• medical, dental and vision coverage
• life insurance
• disability insurance
• 401(k) savings plan
• flexible spending accounts
• employee assistance program
• tuition reimbursement program
• voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
• sick time policy
• flexible vacation policy
• parental leave policy