Associate Director, Connect Process

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

The Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients. The Connect function within the CTC organization is a centralized process department that specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations.

The Associate Director, Connect Process supports process analysis and documentation for the Clinical Operations organization within a fast-paced and highly regulated environment. In addition, they may have multi-project responsibilities and serve as a project manager as needed on complex initiatives and working groups.

Key Responsibilities:

• Drives assigned initiatives/projects and working groups ensuring progression to achieve timelines.

• Oversees Clinical Operations process management/improvement and associated procedural documentation in collaboration with business process owners, cross-functional stakeholders, and subject matter experts.

• In collaboration with R&D Quality's Process, Documentation & Learning team, provides expert direction to teams to business process owners, cross cross-functional stakeholders, and subject matter experts

• Performs content review and quality control for a portfolio of documents ensuring alignment with Gilead policies, procedures, and best practices

• Proposes and implements plans to resolve organizational process issues and execute process-related corrective actions resulting from inspections/audits

• Determines actions required to achieve team goals and leverage junior staff accordingly and manage junior staff and develop their capabilities in alignment with organizational priorities

• Synthesizes operational/performance/compliance data and present business cases clearly to initiative review committee(s)

• Collaborates with key stakeholders to assess process alignment and prioritize revisions as necessary to ensure continued relevance and applicability of processes and associated procedural documents

• Collaborates with Clinical Operations and/or Development change management leads to ensure appropriate change management strategies are defined and executed

• Collaborates with Connect Learning and advises on the development and delivery of training

• Collaborates with Connect Quality and implements process changes resulting from audits/inspections

• Drives standardization and the adoption of best practices across the Clinical Operations organization

• Ensures Clinical Operations processes and associated procedural documents are aligned with industry and regulatory expectations/regulations (i.e. 21 CFR, ICH E6 (R2))

• Leads and supports efforts to increase compliance awareness, a culture of compliance and inspection readiness

Basic Qualifications:

• Bachelor's degree and 10+ years of relevant experience; OR

• Masters' degree and 8+ years of relevant experience; OR

• PhD and 5+ years of relevant experience

Preferred Qualifications:

Project Management Fundamentals

• Navigates projects amidst ambiguous situations and changing priorities

• Manages multiple projects while monitoring quality work product from self and team

• Aligns stakeholders, manages project scope, and drives teams to achieving timelines

Core Technical Skills

• Analyzes problems and logically structure problem-solving strategies to resolve identified/anticipated

• Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies

• Fluency with Microsoft Office suite, including MS Visio and Project

• Strong interpersonal and negotiation skills

• Awareness of change management strategies being implemented across cross-functional teams

• Synthesizes inputs from various stakeholders into coherent deliverables and outputs

• Collaborates flexibly with virtual and remote team members and colleagues

• Directs multiple projects in alignment with overall business objectives

• Communicates complex datasets and findings to relevant stakeholders

Interpersonal Skills

• Strong change champion with a good understanding of change management strategies

• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $195,670.00 - $253,220.00. 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*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , 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 View email address on gilead.yello.co for assistance.

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

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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For Current Gilead Employees and Contractors:

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