Executive Director Clinical Development, Inflammation Therapeutics (MD)

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Job Description
 

POSITION OVERVIEW:

You will lead a portfolio of clinical trial programs in Liver Inflammation & Fibrosis clinical development, including primary biliary cholangitis (PBC), and/or metabolic dysfunction-associated steatohepatitis (MASH) for the assigned molecule(s) / product(s). The ideal candidate would have a strong clinical background in hepatology, along with experience in drug development. You may act as or oversee other Clinical Development Leads and Physician Responsible across the assigned project portfolio. You will be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across your project portfolio. You will lead or otherwise oversee and direct the development, implementation and execution of the clinical development strategy for the assigned molecules / products, which will include development of the Target Product Profile and Clinical Development Plan. Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.

EXAMPLE RESPONSIBILITIES:

• Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.
• Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules/products
• Routinely represents the assigned molecules / products in cross-functional steering and /or governance committees.
• May lead the Global Development Team (GDT) for assigned molecules and / or assign GDT leadership to direct reports to ensure clinical development project deliverables and timelines are consistently met.
• May act as a core team member on the Program Strategy Team or assign this role to direct reports to ensure appropriate clinical development input and direction into the full lifecycle management of assigned products.
• Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products.
• In general, serves as the lead for communications, both written and oral, with health authorities, including but not limited to those clinical development activities relevant to global registration for assigned molecules/products
• Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Leads or otherwise oversees and directs the clinical development component(s) in the preparati