Sr. Director, Clinical Development - Md (Oncology/Hematology)

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description
EXAMPLE RESPONSIBILITIES:

• 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.
• Leads or otherwise oversees and directs the Clinical Development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
• 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.

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 6+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Board certification in Oncology is preferred, including familiarity with clinical solid tumor and/or hematologic medicine.
• 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.

Knowledge & Other Requirements

• 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.
• 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.
• When needed, ability to travel.

The salary range for this position is: $266,815.00 - $345,290.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.