Senior Director, Technology and Innovation - Global Development / Clinical Operations

Location
Foster City, CA
Posted
Jul 21, 2021
Ref
2304501
Required Education
Bachelors Degree
Position Type
Full time
Senior Director, Technology and Innovation - Global Development / Clinical Operations
United States - California - Foster CityUnited States - Remote

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

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Senior Director, Technology and Innovation - Global Development / Clinical Operations

* This position is located in Foster City, California or may be located Remotely within the United States

POSITION OVERVIEW

Establish and support the strategy, framework, and resource requirements for the transformation of the clinical trial model including the adoption of human-centered design methods, technology and data to optimize our patient focused, decentralized clinical trial capabilities.

The Senior Director must have extensive experience in global clinical development with expertise in clinical trial data management to support technology innovation and integrate it with Gilead\'s existing clinical trial methodologies. As a senior leader, you will make valuable contributions by improving our competitive advantage using innovative clinical trial design and emerging technologies to transform the patient experience throughout the drug development process.

This role will closely partner with the functional and department heads throughout the Development organization including, but not limited to, Clinical Data Science, Clinical Data Management, Clinical Operations, Clinical Research, Regulatory, Patient Safety, Patient Privacy, Quality & Compliance, and other relevant groups to deliver on the organizational strategy of providing a modern, human-centered patient experience in clinical research. In this position, you will ensure clinical programs are conducted to meet program/project objectives, with close attention to budget, speed, and quality.

The Senior Director will report directly into the Executive Director, Technology & Innovation and be responsible for project and people resource management including project leadership, project governance, project management, employee new hire, retention activities, performance and rewards management, and succession planning. You will have the opportunity to mentor and develop junior department members and project team partners with and without direct line management responsibility.

KEY RESPONSIBILITIES FOR POSITION:
  • Establish data governance and stewardship position & strategy in alignment with clinical data science data governance model to support emerging technology platforms that transform the patient experience in clinical trials
  • Early-Stage Development: Define and establish the development framework and environment to test emerging technology off portfolio within the Neo Labs development construct
  • Late-Stage Development: Partner with clinical data science to establish workflows to enable machine learning tools to support trial execution, data acquisition, data processing and analysis within the new paradigm
  • Define parameters with relevant business partners to determine the framework and model for enabling patient safety, patient privacy & security, measurement validity, and data integrity
  • Leverage the development and functional data governance model to ingest structured and unstructured data to support experimentation, testing, validation, and implementation to deliver the new experience and transformational outcomes for patients and the business
  • Develop the short- and long-term metrics for success in delivering the new paradigm
  • Partner with the design process and team to capture patient and business requirements and provide insight into updates on the capability roadmap as it relates to emerging platforms
  • Develop a global network of resources to establish position papers and processes through the innovation hubs
  • Partner and develop the strategy for global regulatory engagements in partnership with regulatory leadership to inform the global innovation strategy for the development of new digital capabilities
  • Align with the head of Real World Evidence to prioritize the development of key capabilities to deliver on our innovation strategy
  • Partner with the new design center to integrate new capabilities into the digital playbook for program/study teams
  • Build external relationships with key consortia, regulatory agencies, and partners as a thought leader in clinical data management
  • Identify new sources of innovation from startups, small and mid-sized organizations utilizing a variety of strategic partnership models to share risk and value while gaining significant advances in the speed of delivering new solutions
  • Provide leadership and oversight for the successful management of international clinical trials (Phase I - IV) across multiple indications through clinical study teams and using CROs and/or internal resources
  • Provide departmental financial oversight, managing spend as planned and ensuring appropriate communication with clinical and corporate finance departments
  • ead and participate in collaborative SOP development, project team governance documents (clinical development plans, RFD, RF2, RF3), Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents, as well as abstracts, presentations and manuscripts
  • Collaborate cross-functionally on due-diligence efforts and assessments for mergers and acquisitions as appropriate
  • Collaborate with regulatory, medical affairs and commercial to assist with lifecycle management of approved drug products
  • Support Gilead Public Relations and external corporate giving, or Employee Resource Group (ERG) initiatives (e.g. community service).


KNOWLEDGE, EXPERIENCE AND SKILLS:
  • Extensive working knowledge of clinical trial conduct and recent advances in data science and technology
  • Prior experience leading the transition from a "traditional" clinical trial model to a technology enabled platform focused on patient centric clinical trial design and conduct
  • High degree of customer focus and collaboration in a team environment
  • Excellent verbal and written communication skills
  • Demonstrated planning and organizational skills including project management
  • Able to prioritize various responsibilities and timelines and to adapt quickly to changing circumstances
  • Inspirational leadership style for high performance, attracting talent and communicating effectively to influence with impact
  • Advanced capabilities in Change Management and Business Transformation initiatives
  • Strong Leadership Capabilities including resource allocation, organizing teams, strategic vision, and ability to drive for results through teams
  • Strong command of solving complex problems and use of highly developed independent judgement relating to domestic and global regulations, guidelines, investigator interactions, and timelines
  • Prior experience in the oversight and management of regulatory inspections (FDA, EMA, MHRA, PMDA, NMDA) in collaboration with Regulatory Compliance
  • Track record for effectively communicating scientific, medical, and organizational concepts to internal and external customers
  • Extensive interpersonal skills, an ability to lead multifunctional teams, and to manage staff and mentor and develop junior staff
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
  • Experienced with influencing across a matrix and creating a clear sense of direction


Job Requirements
  • 12-14+ yrs relevant experience and 8+ years in a Leadership Role and a BS or BA Degree in a related discipline
  • Extensive working knowledge of clinical trial conduct and recent advances in data science and technology
  • Prior experience leading the transition from a "traditional" centralized clinical trial model to a patient centric, technology enabled, decentralized clinical trial experience
  • High degree of customer focus and collaboration in a team environment
  • Excellent verbal and written communication skill

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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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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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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