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Sr. Director, Clinical Development - Md (Oncology/Hematology)
Company | Gilead Sciences |
Address | Foster City, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-09-08 |
Posted at | 9 months ago |
For Current Gilead Employees And Contractors
- In general, serves as the lead for communications, both written and oral, with health authorities.
- Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
- Develops thought leader and other external relationships that can guide short- and long-range clinical development strategies and direction for assigned molecules /products.
- May assist in the clinical evaluation of business development opportunities.
- 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 lead the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.
- May also manage one or more direct reports.
- Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Routinely represents the assigned molecules / products in cross-functional steering and /or governance committees.
- 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.
- Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products.
- Presents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publications.
- Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
- May act as a core team member on the Program Strategy Team, which is responsible for the full lifecycle management of the assigned products.
- Board certification in Oncology is preferred, including familiarity with clinical solid tumor and/or hematologic medicine.
- Multiple years’ experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting or academia.
- Multiple years’ line management (direct reports) experience is preferred.
- Experience in the biopharma industry is strongly preferred.
- Experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
- MD or equivalent with 6+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
- Extensive experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
- Demonstrated excellence leading large and complex teams in life sciences, healthcare, consulting or academia.
- 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.
- Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans.
- Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
- When needed, ability to travel.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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