You may act as a Clinical Development Lead and Physician Responsible for clinical trial programs in Liver Fibrosis clinical development, including nonalcoholic steatohepatitis (NASH) and/or primary sclerosing cholangitis (PSC), for the assigned molecules / products. 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 leading development of the Target Product Profile and Clinical Development Plan. 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. You will lead meetings with academic study investigators, key advisory meetings, and may participate in interactions with regulatory health authorities. In this role, you 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 fibrosing ILDs
- 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 clinical study reporting for assigned molecules / products.
- In general, serves as the lead for communications, both written and oral, with health authorities.
- Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Will be part of a team responsible for the preparation/review of regulatory documents including but not limited to IND annual reports, IND safety reports, investigator brochures, and development plans, as well as managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections. May directly manage or delegate and oversee the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results, and scientific presentations.
- Presents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publications.
- May assist in the clinical evaluation of business development opportunities.
- Develops thought leader and other external relationships that can guide short- and long-range clinical development strategies and direction for assigned molecules /products.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
- May also manage one or more direct reports.
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.Minimum Education & Experience
Knowledge & Other Requirements
- MD or equivalent with 6+ years' clinical, scientific, and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
- Board certification in gastroenterology and/or hepatology is preferred, including familiarity with chronic liver diseases.
- Experience in the biopharma industry is strongly preferred.
- Multiple years' experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting or academia.
- Extensive experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
- Multiple years' line management (direct reports) experience is preferred.
- Experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
- Demonstrated excellence leading large and complex teams in life sciences, healthcare, consulting or academia.
- Has an expert-level of knowledge of drug development, as evidenced by a proven track record in setting short- and long-range drug development strategies and plans.
- Has a thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
- Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees. Able to distill complex matters into a clear business case and roadmap for execution.
- Ability to think analytically and strategically to formulate, develop, and execute clinical plans
- Strong leadership skills with an ability to set vision, lead change, and mentor others
- When needed, ability to travel.
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