Senior Director, Clinical Data Standards

Senior Director, Clinical Data Standards
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 #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description


Senior Director, Clinical Data Standards

Job Description

The Sr. Director, Clinical Data Standards is responsible for driving the strategy for data standards and processes across the clinical data continuum for quality of deliverables and global data interoperability, in compliance with industry standards and regulatory requirements, and business requirements. This role leads Clinical Data Standards organization and actively participates in and influencing Clinical Data Standards forums (internally or externally) to maintain awareness of any initiatives and trends that could be incorporated into or enhance Therapeutic Area Clinical Data Standards.

In collaboration with the Clinical Data Standards Governance Council, this role leads the development, deployment, maintenance, and governance of the Gilead Clinical Standards. This role supervises and is accountable for the development of end-to-end clinical data standards to enforce proper utilization of standards, drive adherence to standards processes, and the timely, thorough assessment of enhancements and deviations. In collaboration with Developmental Operations Systems and Process, this role supports identification, review/evaluation, deployment and usage of technologies to report and assess internal standards compliance .

This role builds relationships across the global organization and strategic service providers and is comfortable interacting and influencing internal and external teams of all levels, including Senior Management, to model the advocacy for Data Standards. This role applies critical thinking and problem-solving in a high volume, fast-paced environment and drives the evolution of data standard components to match the evolving new practices of medical science.

Responsibilities

• Serves as a thought partner for vision, defining clear annual goals, and build realization metrics for the creation, maintenance, and usage of data standards.
• Overall responsible for the development, maintenance, and strategy of the Gilead global and therapeutic area clinical data standards. Strategizes the maintenance and decommissioning of Clinical Data Standards models (including but not limited to: CDASH, SDTM, Controlled Terminology, ADaM, TFLs and questionnaires).
• Provides input to functional governance with strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from vendor(s) and/or cross-functional teams.
• Responsible for standards governance. Chairs the Clinical Data Standards Governance Council, setting the agenda, to ensure adherence to standards, develop new standards and enhancements to existing standards. Manages and communicates the actions reflective of the decisions made by the Clinical Data Standards Governance Council.
• Acts as a champion for change and is the CDS business lead for new system(s) and technologies managing data standards objects.
• Oversees the maintenance of SOPs, process maps and templates and timelines related to Gilead clinical data standards.
• Understands and advises on functional priorities within the context of enabling larger organizational success.
• Collaborates and coordinates in developing a training strategy and ensures consistent training programs for clinical data standards.
• Maintains awareness of the evolving landscape of industry and regulatory and provides leadership for compliance.
• Provides influential guidance to study team balancing science with productivity of reuse. Liaisons with various functional areas on escalations (e.g., dealing with issues to address delays or provide alternate solutions to meet timelines).
• Represents function in external professional initiatives and organizations such as CDISC, pHUSE, SCDM, SCOPE, PharmaSug, TransCelerate, Accumulus, DIA, etc. to identify industry best practice and increase the visibility of the company. Maintains awareness of the evolving landscape of industry and regulatory and provides leadership for compliance.
• Defines and/or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
• Anticipates resource needs and works with senior management and HR to ensure adequate long- term resource allocation.
• Acts as a strong coach, mentor, and leader, providing clear prioritization and direction to fellow colleagues and direct supervised staff. Supports development growth for his/her team members.

Qualifications

• 14 years of experience and a BS degree in Biostatistics/Computer Science or equivalent health-related, life science area or technology-related fields.
• 12 years of experience and a MS degree in Biostatistics/Computer Science or equivalent in health-related, life science area or technology-related fields.
• 12 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent in health-related, life science area or technology-related fields.
• 12 years personnel management or equivalent.
• 12 years industry experience with all phases of development in one or more therapeutic areas preferred.
• Superlative expertise in Clinical Data Standards and terminology in order to build a new culture and support a new mission for clinical trial execution related to data collection and analytical deliverables.
• Be an industry thought leader on clinical data standards, with preferable past experience in contributing to industry publications, articles, and consortiums related to the field of data standardization.
• Proven success record of working in a global matrixed environment and regularly collaborating with cross-functional teams, such as clinical trial operations, biometrics, IT, business-led technology organizations, and external vendors.
• Excellent communication skills and is comfortable interacting and influencing internal and external teams of all levels.
• Ability to handle multiple development programs simultaneously.
• NDA/CTD Experience preferred.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Expert knowledge of regulatory and clinical study data submission requirements for FDA, EMA, and ROW (Rest of the World), and of ICH regulations and of industry standards.
• Minimum of 6 years of experience in developing and managing clinical data standards or drug development process, with expertise in the cross-functional interfaces with Biometrics functions (e.g., Data Management, Statistical Programming, Biostatistics, Medical Writing).
• Proven ability to challenge current business standards and processes, with a track record of proposing effective solutions to problems.
• Demonstrated negotiation skill to reconcile differing viewpoints and opinions into actionable decisions.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.






jeid-0b10ae1d5c9fd1418f7ebe8373613c94