Senior Director, Clinical Operations - Quality, Compliance & Process Improvement
Senior Director, Clinical Operations - Quality, Compliance & Process Improvement
United States - Arizona - Tucson
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. Gileads 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 companys five core values. Thats 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
Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialization of Gilead's products.
Do you have a passion for Quality/Compliance, Process Improvement, and Learning & Knowledge Management in executing clinical trials? If so, we have an exciting opportunity tailor made for you!
Gilead is looking for a new Senior Director, Clinical Operations CONNECT, as a key member of Clinical Operations leadership team to help establish the strategy for the CONNECT group to increase Quality, optimize process, and deliver highly effective Learning and Knowledge Management for Clinical Operations.
The ideal candidate will have experience in clinical trial quality processes, SOP's, optimization, learning, and communication that may apply to existing Gilead clinical trial methodologies. As a senior leader, you will make valuable contributions by improving our processes and learning to enable better clinical trials. This role will closely partner with the Department Heads of each Therapeutic Area within the organization and will ensure clinical programs are conducted to meet project goals with close attention to quality, process and continued learning.
The Senior Director will report directly into the Vice President, Clinical Operations and will include functional management of the current team which is approximately 20 people with growth as needed. In this role you will lead subordinate directors and people managers and will be responsible for resource management including employee new hire, retention activities, performance and rewards management, and succession planning for this department. You will have the opportunity to mentor and develop junior department members and project team partners.
- Lead Clinical Operations CONNECT department, which includes Quality, Process Improvement, and Learning and Knowledge Management
- Drive, develop, simplify and finalize processes which drive continuous quality improvement and enhances operational excellence across the organization
- Respond to and collaborate with Regulatory Compliance on CAPAs that require changes to Clinical Operations wide process modifications
- Drive, establish Clinical Operations quality standards and work processes; function as a controller of Clinical Operations process changes and function as a SME/advisor on Clinical Operations process as needed
- Interact independently and negotiate process improvements/solutions with process owners, subject matter stakeholders, and functional area teams
- Oversees creation of Business Enabling Documents (BEDs) associated with SOPs and WRKs
- Oversees Clinical Standards Committee and process standardization
- Direct Knowledge & Learning management staff on roll-out of training and oversee review of all internal and external (to preferred vendors) communications
- Keep abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to Clinical Operations processes and proactively initiates discussions and process changes so the company is prepared to respond appropriately
- Represent Clinical Operations at professional Quality meetings and may present company initiatives at such events; collaborate with other pharma industry leaders in Quality on industry initiatives
- Lead efforts to increase the commitment to quality in individuals and a culture of quality within the organization
- Build infrastructure, enhance and optimize Clinical Operations CONNECT department
- Manage and grow the department as needed; monitor resources and budget; ensure adequate resourcing of CONNECT Clinical Operations organization, develop staff and maintain a succession plan
- May represent Clinical Operations at worldwide regulatory inspections
Specific Knowledge & Skills:
- Must have a highly developed knowledge of worldwide GCP regulatory requirements
- Understands current global and regional trends in regulatory compliance and ability to assess the impact of these requirements to the business
- Clinical Operations knowledge and management background
- Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines
- Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems
- Understands impact of decisions and actions on business and consults with appropriate colleagues and management
- Considers a number of factors in planning, anticipate work and prioritize work to meet tight timelines
- Mentors others and promotes productive working relationships
- Acts as a role model for change by demonstrating commitment
- Addresses sensitive issues in an objective manner
- Is recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource
Minimum Education & Experience Requirements:
- Bachelor's degree with 12+ years or Master degree with 10+ years of relevant experience working in a pharmaceutical clinical operations AND quality control/quality assurance/compliance environment
- Proven effective verbal, written, interpersonal skills to include delivering presentations to executive staff
- Demonstrated ability to lead multi-functional teams; manage staff and mentor junior staff
- Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
- Demonstrated excellence in complex project management and effectively managing multiple projects/priorities
- This position is located in Foster City, California and may require domestic or international travel as required
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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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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:
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