Description:
You will typically lead multiple components of clinical trial programs in IBD/inflammation clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable or various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, 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:
- Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
- Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
- Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
- Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
- Coordinates the collection and assimilation of ongoing data for internal analysis and review.
- Coordinates and manages 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.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
REQUIREMENTS:
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
- MD or equivalent with 4+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
- Board certification in Gastroenterology is preferred, including familiarity with IBD management or inflammatory disease management..
- Experience in the biopharma industry is preferred.
- Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
- Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
- Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.