Associate Director, Clinical Operations Learning & Knowledge Management

Location
Foster City, CA
Posted
Oct 27, 2021
Ref
2588435
Required Education
Associate Degree
Position Type
Full time
Associate Director, Clinical Operations Learning & Knowledge Management
United 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


Associate Director, Clinical Operations Learning and Knowledge Management

The Associate Director (AD) is responsible for providing Subject Matter Expertise (SME) in support of the Clinical Operations Organization and associated Learning, Communications and Process teams. The AD will be a knowledge resource in all aspects of Clinical Trial Management including Study & Site Management, Vendor Oversight, Regulatory Compliance and Inspection Readiness. This role will serve as a key contributor to the development and maintenance of various ClinOps training curriculum, including Onboarding, Role-specific Process Training and Professional Development Programs ensuring all training reflects current industry best practices and regulatory standards in line with associated internal processes and systems.

This role will also independently, or with the support of the learning organization, facilitate in person or virtual training workshops, presentations or programs to support continual learning opportunities for ClinOps associates. This position plays a key role in ensuring a focus on quality within the ClinOps organization and may support management in the development, monitoring and delivery of related key performance metrics. The AD may also serve as the ClinOps (SME) in cross functional working groups; and may also contribute to the execution of Corrective Action Preventative Action (CAPA)s as it pertains to training directives.

In this role the AD will also be expected to proactively identify knowledge gaps and areas in need of additional or future training/communications support. They will drive continuous process improvements and contribute to the development of on-going training/tools for new /existing staff. Influences departmental decisions, as appropriate, and understands/aligns priorities and deliverables with long-term business needs. They will provide mentorship, task oversight and/or line management of junior training staff on applicable programs, processes and systems as needed.

Core Responsibilities:

  • Lead the design, development, and implementation of learning programs across Clinical Operations (CO).
  • Lead Good Clinical Practice (GCP) training and development.
  • Support CO as a GCP Subject Matter Expert.
  • Lead and guide new hire orientation, onboarding and knowledge/skill-based practicum training.
  • Partner with management to define training needs through determination of knowledge gaps and needs assessment. Stay abreast of industry best practices and affiliated publications, memberships, and technologies to ensure organizational goals are met.
  • Actively seek out new, cutting edge technology to further improve training initiatives and build efficiency.
  • Support process for evaluating training effectiveness; revise training and/or training plan as needed. Identify, develop and deploy appropriate learning mechanisms to include: instructor-led, web-based, & read and acknowledge training.
  • Drive strategic management of Learning Management Systems (LMS).
  • Implement training activities and projects with other functional areas and across Clinical Operations locations.
  • Incorporate motivating, creative, and interactive training techniques to enhance the training experience, in an effort to maximize learning and retention. Plan and organize large scale training initiatives.
  • Mentor junior staff and provide guidance related to instructional design, development, and building business acumen.
  • Develop innovative employee communications in support of Clinical Operations.


Required Knowledge & Experience

  • 10+ years of experience and a BS or BA in a relevant scientific discipline or 8+ years of experience and an MS or MBA.
  • Understanding of learning principles and application in a technical business environment.
  • Experience in the learning design and development process required.
  • Ability and experience in training development and delivery on critical aspects of Clinical Trial Management such as ICH/GCP Guidelines, Monitoring Oversight, Site Interactions, non-compliance, Risk management, Inspection readiness etc. is required.
  • Prior people/team and project management experience required.
  • Excellent communication, presentation and facilitation skills; ability to write clearly and summarize information effectively as well as present complex information to diverse audiences.
  • Ability to plan, organize, coordinate, manage and execute with minimal guidance and effectively navigate ambiguity.
  • Clinical operations or study management experience a required.
  • Excellent teamwork, communication, decision-making and organizational skills are required.
  • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
  • Must be able to prioritize multiple tasks.
  • Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
  • Experience with Instructional/Learning design principles and application in a technical business environment is desired.
  • Experience within a pharmaceutical/biotechnology organization is preferred.
  • Ability to travel up to 20%, primarily onsite to Gilead campus(es) i.e. US-CA, NJ; UK.


Gilead Core Values

  • Integrity (Doing What's Right)
  • Inclusion (Encouraging Diversity)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)


As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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.

#LI-JL2


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. 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 ‘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.

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