Sr Director, Clinical Development Inflammation and Fibrosis

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Job Description
 

You may act as a Clinical Development Lead and Physician Responsible on clinical trial programs in the Inflammation and Fibrosis therapeutic area. Clinical development activities include molecules / products targeting primary biliary cholangitis (PBC), other cholangiopathies, and metabolic dysfunction-associated steatohepatitis (MASH). The ideal candidate would have a strong clinical background in hepatology, along with experience in drug development.  As Clinical Development Lead, you will be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials for the assigned molecules /products. You may take the lead on the development, implementation, and execution of the clinical development strategy for the assigned molecules / products, which will include constructing Clinical Development Plans and contributing to Target Product Profile development. Additional 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. He/She will lead meetings with academic study investigators, key advisory meetings, and may participate in interactions with regulatory health authorities. This person will interact closely with the therapeutic area's senior management team.

EXAMPLE RESPONSIBILITIES:

• Integrates with a team providing matrix leadership that ensures execution of innovative, highly proficient and feasible strategies for drug development specific to a portfolio of therapeutics targeting inflammatory & fibrotic diseases
• Seeks to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
• Will serve as a scientific and clinical resource with the liver fibrosis organization at Gilead
• 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 development of the Target Product Profile and Clinical Development Plan for assigned molecules / products
• May lead the Global Development Team for assigned molecules; providing scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines
• May act as a core team member on the Program Strategy Team, which is responsible for the full lifecycle management of the assigned products
• Leads or otherwise oversees and directs clinical trial protocol design and cli