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

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical developmentstudy designprotocol writingdata analysisscientific interpretationbiostatisticsdata managementclinical operationsregulatory submissionsclinical trial management

Soft Skills

leadershipcollaborationindependenceproblem-solvingcommunicationintegrityaccountabilityadaptabilitycreativityteamwork

Certifications

MDboard certified hepatologist