United Spinal Association Jobs

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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 Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include liver viral illnesses, inflammatory diseases, and cancer.

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.

You will oversee and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility. You will be responsible for the resource management of studies, including ongoing assessment of resource needs and optimal deployment of resources. You may act as the business process owner (BPO) and/or serve as a subject matter expert for Clinical Operations processes. You will encourage an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking and standardization across Clinical Operations.

Job Responsibilities

• 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 guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.

• May lead cross-functional Study Management Teams (SMTs) and influence all relevant stakeholders.

• Partners with cross-functional teams to manage, adjust and revise project timelines and budgets as needed.

• Communicates project status and issues and ensures project team goals are met in alignment with project decisions. Escalates issues as needed.

• Participates in the development of all study-related documentation, including study protocols.

• Participates in the selection and management of contract research organizations (CROs) / vendors, including development of requests for proposals (RFPs).

• Anticipates obstacles and difficulties and implements solutions to achieve project goals, including risk assessment and mitigation strategies.

• Resolves issues as needed within national and international regulations and guidelines.

• Uses all available tools to track, oversee and communicate on program status to all key stakeholders.

• Participates in and/or leads departmental or interdepartmental strategic initiatives.

• As assigned, initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training.

• Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.

• Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.

Requirements

Minimum Education & Experience:

• BA / BS / RN with 8 or more years’ relevant clinical or related experience in life sciences.

• Typically has a minimum of 4 years’ cross-functional global 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.

• Proven ability to successfully start-up, manage and close-out clinical studies, including authoring clinical study and regulatory documentation and SOPs.

Knowledge & Other Requirements:

• Advanced knowledge of one or more disease or therapeutic areas, as evidenced by independence in designing, implementing and managing study team plans, deliverables and resource management.

• 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.

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

• Ability to lead and influence programs, projects and/or initiatives.

• Strong interpersonal skills and understanding of team dynamics.

• Proven ability to work successfully in a team-oriented, highly-matrixed environment.

• Demonstrated effectiveness in proactively managing change.

• Strong communication and organizational skills.

• When needed, ability to travel.

Gilead Core Values

• Integrity (always doing the right thing)

• Teamwork (collaborating in good faith)

• Excellence (working at a high level of commitment and capability)

• Accountability (taking personal responsibility)

• Inclusion (encouraging diversity)

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.