Associate Director, Connect Process

Gilead Sciences•Foster City, CA

1d•Onsite

About The Position

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.

Requirements

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
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
Synthesizes inputs from various stakeholders into coherent deliverables and outputs
Communicates complex datasets and findings to relevant stakeholders

Nice To Haves

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
Analyzes problems and logically structure problem-solving strategies to resolve identified/anticipated
Awareness of change management strategies being implemented across cross-functional teams
Collaborates flexibly with virtual and remote team members and colleagues
Directs multiple projects in alignment with overall business objectives
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.
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.

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.
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.