Director, Clinical Data Management
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossibleFor Current Gilead Employees and Contractors:
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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.
Clinical Data Management (CDM) supports drug discovery, development and marketed products across Gilead by ensuring the accurate and timely acquisition, analysis and reporting of diverse clinical data through CRF / eCRF design, editing specifications and query resolution processes. CDM also manages data transfers from vendors, such as central labs and others.
You will typically lead a large team of direct reports and may manage other people leaders. You will typically be responsible for a team supporting a portfolio of products or indications within a therapeutic area. You will be responsible for overseeing CDM teams to execute CDM activities for the assigned area. You will ensure appropriate consultation to study management and other cross-functional teams on all matters related to CDM processes, systems and deliverables. You may act as CDM lead or otherwise oversee CDM support on regulatory submissions, audits, inspections and inquiries. You will lead CDM strategy development for the assigned area and development and implementation of CDM policies, SOPs, processes, documents and other tools. You will routinely represent CDM to cross-functional groups, teams and leaders. You may be a standing member of the CDM Leadership Team with additional responsibilities for developing the group's short- and long-range strategies, infrastructure and capabilities.EXAMPLE RESPONSIBILITIES:
- Leads and manages a team of direct reports and may manage other people leaders. Hires, develops and retains diverse top talent in the team. Sets clear and elevating goals for the team and individual direct reports. Coaches team on their performance, development and career interests.
- May serve as lead for multiple products or indications of considerable complexity within a therapeutic area, including leading cross-functional working groups. Responsibilities may include managing implications of studies outside the U.S.
- Leads CDM strategies for the assigned area.
- Ensures timely review of study protocols and assistance to site coordinators, investigators, and field clinical staff in collecting data to meet protocol requirements in a timely manner.
- Ensures timely identification, tracking and resolution of CDM queries and issues.
- Ensures timely and appropriate consultation to study management teams and for Clinical Development regarding data management issues.
- Works collaboratively with other colleagues to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
- Ensures completeness, accuracy and consistency of routine clinical data and data structure.
- Ensures adherence to standard business processes within CDM systems to assure compliance with regulatory requirements.
- Oversees and directs the design and implementation of the CDM process with vendors, including data entry, data quality checking, data transfer, reporting, backup and recovery.
- Ensures study teams and vendors are appropriately educated on CDM processes and deliverables, including deviations from established processes.
- Oversees and directs the preparation of CRF/eCRF design.
- Leads or otherwise oversees CDM support on regulatory submissions, regulatory / compliance audits and inspections and other relevant regulatory inquiries.
- Provides technical and business process expertise on new and emerging technologies / vendors for clinical trial execution.
- Leads or otherwise oversees development, review and implementation of continuous improvements, processes, policies, SOPs and other guidance / process documents for CDM.
- Leads or otherwise oversees initiatives to gather, organize, and analyze interim clinical data from various data sources.
- Ensures timely and appropriate escalation of complex issues to senior management, e.g., system down-time, vendor performance issues, legacy trial rescue from acquisitions, etc.
- Owns and manages the budget and resource plans for assigned area.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs and ensures the same across own team.
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
- PhD in life sciences or related discipline with 8+ years relevant CDM or other data analytics / data management experience.
- MA / MS in life sciences or related discipline with 10+ years' relevant CDM or other data analytics / data management experience.
- BA / BS in life sciences or related discipline with 12+ years' relevant CDM or other data analytics / data management experience.
- Minimum of 6 years' cross-functional project management or leadership experience in CDM, including multiple years' experience managing project teams.
- Typically has significant line management (direct reports) experience with proven effectiveness and success in hiring, managing and developing diverse top talent.
- Demonstrated excellence in complex project management and effectively managing multiple projects and priorities.
- Demonstrates strong capabilities in hiring, managing and developing diverse top talent.
- Has extensive knowledge of the biopharma industry and the multiple functions and roles involved in drug discovery, development and post-marketing.
- Recognized as a CDM subject matter expert.
- Extensive knowledge of FDA / EMA regulations, NDA and other regulatory requirements, and web-based EDC and CDM systems, as evidenced by ability to effectively advise CDM and cross-functional teams and leaders on complex projects and CDM requirements for a large portfolio of projects.
- Extensive knowledge of the global regulatory process.
- Extensive knowledge of practices, processes and standards for development, validation, execution, maintenance, documentation and archival of clinical data for regulatory submissions.
- Proven abilities to apply business acumen to strategic scientific projects.
- 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.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
- Oncology experience strongly preferred.
- When needed, ability to travel.
The salary range for this position is: $199,835.00 - $258,610.00. 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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