Executive Director, Head of 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.
Job DescriptionPOSITION OVERVIEW:
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 lead a large group or the overall group in CDM. Your team is typically responsible for CDM deliverables across multiple functions and workstreams. You will provide leadership to your own team, which includes direct and indirect reports, and matrix management and leadership to multiple functions, leaders and teams across Research, Development, and other Gilead groups. You will be a standing member of the CDM Leadership Team with leadership responsibilities for developing and evolving short- and long-range CDM strategies, plans and infrastructure development.KEY RESPONSIBILITIES:
Leads and oversees the following activities:
- Hires, develops, and retains diverse top talent on the team. Sets clear and elevating goals for the team and individual direct reports. Coaches team on their performance, development, and career interests.
- Makes significant contributions to our abilities to hire, develop and retain diverse talent with impact in and outside own team
- Drives the ongoing development and refinement of CDM strategies, processes, standards, practices, efficiencies, and capabilities
- Identifies and oversees continuous process improvement, including development and updating of CDM SOPs, standards, systems, practices, policies, procedures, and other tools
- Monitors industry and regulatory best practices and recommends industry leading changes to existing CDM practices
- 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
- Identification, tracking and resolution of CDM queries and issues
- Appropriate consultation to study management teams and for Clinical Development regarding data management issues
- Project deliverables and timelines for clinical data acquisition, quality checking and reporting are consistently met to the expected standards and requirements
- Completeness, accuracy and consistency of routine clinical data and data structure
- Adherence to standard business processes within CDM systems to assure compliance with regulatory requirements
- Appropriate CDM processes are implemented with vendors, including data entry, data quality checking, data transfer, reporting, backup, and recovery
- Study teams and vendors are appropriately educated on CDM processes and deliverables, including deviations from established processes
- Timely and appropriate preparation of CRF/eCRF design
- CDM support on regulatory submissions, regulatory / compliance audits and inspections and other relevant regulatory inquiries
- 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 budget and resource plans for a large portion of or the overall CDM organization.
- 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
- MA / MS / PhD in life sciences or related discipline with 14+ years OR BA / BS in life sciences or related discipline with 16+ years of relevant CDM or other data analytics / data management experience
- Extensive experience leading CDM or related strategies and teams for highly complex business areas and/or workstreams, including short- and long-range strategic planning, governance, and oversight.
- Extensive line management (direct reports) experience. Typically has multiple years' experience managing other people leaders (with indirect reports)
- Proven track record of achieving or exceeding large-scale, complex short- and long-range CDM or related strategies.
- 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.
- Has an expert-level of knowledge of CDM and the latest trends and evolutions in this field, as evidenced by proven track record of leading large-scale, highly complex projects and programs to achieve short- and long-range strategies, plans and objectives.
- 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.
- Proven abilities to make significant contributions to Clinical Data Sciences (CDS) strategic planning and lead significant process improvements in CDS.
- Proven ability to influence up, down and across the organization and externally in a collaborative manner.
- Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives.
- Exceptional interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.
- Strong negotiation and conflict resolution skills.
- Advanced coaching capabilities to mentor/develop staff.
- When needed, ability to travel.
- Demonstrated commitment to Gilead People Leadership Accountabilities (Create Inclusion, Develop Talent, and Empower Teams)
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*.
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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