Assoc Director, Clinical Operations

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
 

• Typically manages a team of direct and indirect reports. Hires, develops and retains diverse top talent on the team. Sets clear goals for the team and individuals direct reports. Coaches direct reports on their performance, development and career interests.  Plays a lead role in developing other people leaders. 
• Provides input into strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation. 
• Provides leadership, guidance, oversight and therapeutic expertise for the successful management of all aspects of clinical trials. 
• Be accountable for China development strategy from operational perspective and drive execution that meets both global standards and local regulatory needs. Strengthen collaboration with CDT to provide impactful China patient insights for GDT consideration and expand China’s role in global trials, accelerating portfolio execution and patient access.
• Responsible for the strategic, operational and financial oversight of assigned program(s). 
• Develops, implements, manages and ensures completion of clinical trials within designated budgets and timelines.
• Sets the strategic vision for assigned clinical trials / programs by working cross-functionally with all relevant stakeholders. 
• Assesses, on-boards, manages and oversees contract research organizations (CROs) and other vendors to ensure success of assigned trials / programs, including requests for proposals (RFPs) and selection processes. 
• Translate the company/department strategy into localized operational tactics for the China team. Performs strategic analysis of project status and issues; ensuring robust risk mitigation strategies are in place. 
• Anticipates complex obstacles and implements solutions to achieve project goals. 
• Solves problems relating to national and international regulations, guidelines and investigator interactions. 
• Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues. 
• Uses all available tools to track, oversee and communicate on program status to all key stakeholders. 
• Contributes leadership input into all study-related documentation, including study protocols. 
• Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
• Initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training. 
• Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements. 
• Build a growth-mindset, AI-enabled Clinical Operations China Team ready to thrive in a rapidly evolving ecosystem.
• Contribute to a bold and agile department mindset that fully embraces change, celebrates successes, learns from failures, and actively pursues continuous improvement.

Requirement and Qualification

• BA / BS / RN with 10 or more years’ relevant clinical or related experience in life sciences.  Or, MA / MS / PharmD / PhD with 8 or more years’ relevant clinical or related experience in life sciences.

• Typically has a minimum of 6 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study management or project teams.

• Experience developing RFPs and selection and management of CROs or other vendors.

• Typically has multiple years’ line management experience.  

• Proven ability to successfully manage clinical studies within designated program budgets and timelines, including significant expertise in authoring clinical study and regulatory documentation and SOPs.

• Meets all requirements for Clinical Program Manager (CPM) grade 29 position with demonstrable proficiency.

• Expert knowledge of one or more disease or therapeutic areas, as evidenced by independence in assuming study management leadership and oversight for multiple clinical studies across a worldwide clinical program.

• Complete knowledge of full cycle study management, from start-up to close-out.

• Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.

• 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.

• Strong financial acumen necessary for the management of clinical trial budgets.

• Proven ability to effectively author clinical study and regulatory documentation.

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

• Strong interpersonal skills and understanding of team dynamics.

• Strong communication and organizational skills.

• Strong negotiation and conflict resolution skills.

• Demonstrates strong capabilities in hiring, managing and developing diverse top talent.

• Demonstrated effectiveness in proactively managing change.

• When needed, ability to travel.

• Typically manages a team of direct and indirect reports. Hires, develops and retains diverse top talent on the team. Sets clear goals for the team and individuals direct reports. Coaches direct reports on their performance, development and career interests.  Plays a lead role in developing other people leaders. 
• Provides input into strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation. 
• Provides leadership, guidance, oversight and therapeutic expertise for the successful management of all aspects of clinical trials. 
• Be accountable for China development strategy from operational perspective and drive execution that meets both global standards and local regulatory needs. Strengthen collaboration with CDT to provide impactful China patient insights for GDT consideration and expand China’s role in global trials, accelerating portfolio execution and patient access.
• Responsible for the strategic, operational and financial oversight of assigned program(s). 
• Develops, implements, manages and ensures completion of clinical trials within designated budgets and timelines.
• Sets the strategic vision for assigned clinical trials / programs by working cross-functionally with all relevant stakeholders. 
• Assesses, on-boards, manages and oversees contract research organizations (CROs) and other vendors to ensure success of assigned trials / programs, including requests for proposals (RFPs) and selection processes. 
• Translate the company/department strategy into localized operational tactics for the China team. Performs strategic analysis of project status and issues; ensuring robust risk mitigation strategies are in place. 
• Anticipates complex obstacles and implements solutions to achieve project goals. 
• Solves problems relating to national and international regulations, guidelines and investigator interactions. 
• Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues. 
• Uses all available tools to track, oversee and communicate on program status to all key stakeholders. 
• Contributes leadership input into all study-related documentation, including study protocols. 
• Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
• Initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training. 
• Ensures team