Gilead’s primary areas of focus include HIV/AIDS, liver diseases, serious respiratory and cardiovascular conditions, cancer and inflammation.

Senior Software Engineer, Research Systems

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
At Gilead, our therapeutic projects demonstrate the best scientific creativity within an efficient, optimized process. In the Research Informatics group, you will be crucial in connecting technology to scientific processes and supporting scientists as they execute drug discovery projects. With your familiarity and interest in software development and an evolving understanding of scientific methods, you will have the capability to significantly enhance efficiency, thereby facilitating the achievement of therapeutic project goals. This role at Gilead supports systems used in both small and large-molecule drug discovery, with solutions developed in-house or integrated from purchased software.

 

Data dashboards, data ports, and tools are deployed for specific projects. Their use evolves as a project advances from hits to leads to advanced leads. As the scientific objectives change, tools and views should be updated to foster innovation and strategic achievement. At Gilead, you will develop an in-depth understanding of the science and technology associated with drug discovery. In this role, you will be part of the cycle and contribute to the project data views, which ensure that decisional data is front and center. You will script, configure, and envision the best way to show data integral to drug discovery.

 

As you support project data, you will assess solution effectiveness while searching for inspiration on the best way for scientists to view data. You will monitor ongoing operations for optimization opportunities to evolve the Informatic infrastructure by responding to and discussing needs and issues with Research.

 

Specific Responsibilities

Responsibilities for this position will include (but are not limited to) the following:

• Works within the Research department to support scientific research.
• Works with research scientists on their analysis (assay data processing; image processing)
• Uses scripting tools (Python and Pipeline Pilot) to integrate or supplement project views.
• Supports an emerging scientific computing environment in AWS.
• Works with day-to-day operations (of Linux workstations, Severs)
• Works alongside scientists to demonstrate tools and prepare user training and documentation.
• Implements and configures scientific software from vendors.
• Works alongside our C# programming group, which is responsible for novel system development and integration.
• Manages the documentation for deployed applications.
• Supports manages and executes test scenarios.
• Collects enhancement requests and defect reports.
• Participates in the registration and curation of putative drugs, ensuring the integrity of research data.
• Proposes and deploys metrics for the value and effectiveness of software.
• Prepares user training and documentation.
• Provides support to end-users on day-to-day operation workflows.
• This role requires a foundation in chemical or biological sciences, a good understanding of technology, and the ability to communicate effectively across the functional areas of Research to advance drug development efforts.

 

Key Responsibilities

• Engagement with scientists to identify pressing data needs for therapeutic projects.
• Ability to quickly develop scientific scripting solutions (in Python or Pipeline Pilot)
• Support for data-driven decision-making by implementing or configuring software.
• Monitors the need for data analysis and visualization software.
• Ability to develop strategies to understand the impact and use of software.
• Shares in the responsibility for change management associated with the system being developed, enhanced, or supported.
• Stays current with cloud, data analytics, visualization technologies, and practical approaches to the use.
• Works as an individual contributor and supporter of scientific projects
• Support for data-driven decision-making with front-line interaction with scientists.
• Frequent communication with management, colleagues, and researchers
• Is knowledge of scripting (in Pipeline Pilot or Python)
• Manages specific project data dashboards and portals under management direction.

 

Minimum Qualifications

Knowledge, Experience & Skills

• 5+ years’ relevant experience with BS / BA

or

• 4+ years’ relevant experience with MS / MA / MBA
• Education in the chemical or biological sciences or a related discipline is preferred.
• Some experience in the laboratory or with programming languages such as C# is encouraged.
• Experience in biotechnology or pharmaceutical company.
• Direct experience or strong familiarity with drug discovery technologies is desirable.
• Demonstrates a proven ability to work collaboratively with cross-functional teams.
• Has the capability to provide insight that will improve processes and operations with software.

 

The salary range for this position is: $117,895.00 – $152,570.00. 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*.

Director, Pharmacometrics

 

The salary range for this position is: $226,185.00 – $292,710.00. 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*.

Sr. Manager, Biostatistics

With guidance, you will lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans and providing biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc.

EXAMPLE RESPONSIBILITIES:

• With guidance, acts as biostatistics lead on clinical studies or other non-molecule projects.
• Where applicable and with guidance, leads statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with other Biostatistics team members and cross-functional partners. Provides statistical consultation on trial design and study endpoints and authors statistical analysis plans. Typically assigned clinical studies or other projects of increasing complexity or size. Depending on area of assignment, may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc.
• Where applicable, oversees and contributes to completion of all technical and operational statistical activities for a group of clinical trials. Directs internal and external teams in the definition, execution and completion of statistical activities for one or more molecules or marketed products of increasing complexity.
• Where applicable, participates in cross-functional clinical development planning for one or more molecules or marketed products to provide the biostatistical perspective and biostatistical input.
• Where applicable, participates in cross-functional protocol design and review discussions.
• Where applicable, advises internal and external partners as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
• Leads the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products.
• Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
• Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for clinical development.
• Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases; performs or supervises data entry.
• Develops enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodologies and tools.
• Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
• May participate in or lead special projects that can benefit multiple Biostatistics team members, such as new methodologies, processes, technology and other tools, and may also participate in the development and / or implementation of SOPs and related documentation.
• Provides matrix management to projects supported.
• Independently defines required resources for assigned work, seeking advice as needed.
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.

 

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia or a related environment. PhD with 2+ years’ biostatistics experience is preferred.
• MS in biostatistics or related discipline with 6+ years’ relevant experience in statistical analysis of biomedical data using SAS software.
• Multiple years’ biostatistics or related experience, including experience effectively leading small projects and project teams.
• Significant biomedical statistical analysis experience and experience working with relevant software.
• Experience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools used typically used by Biostatistics.
• Proven effectiveness managing projects and teams.

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Has advanced knowledge of underlying statistical principles, concepts, practices, standards, processes and tools, and has shown ability to effectively apply this knowledge to achieve targeted outcomes to meet business needs.
• Has advanced knowledge of biostatistics best practices and tools and has shown ability to apply this to improve overall results.
• Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes.
• Understands drug development phases and the nature of associated clinical trials across phases.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
• Strong communication and organizational skills.
• When needed, ability to travel.

 

 

The salary range for this position is: $169,320.00 – $219,120.00.

Associate Director, Clinical Pharmacology – Virology

With considerable independence, you will typically lead clinical pharmacology studies of increasing complexity in Virology focusing on non-HIV therapeutics, which range from first-in human through approval and post-marketing activities including pediatric development. Working in collaboration with others, you are responsible for various aspects of clinical pharmacology program activities. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical pharmacology study start-up/execution/close out, PK-PD and related analysis, interpretation and reporting, and support of regulatory filings. You will typically lead clinical pharmacology cross-functional study sub-teams, which entails coordinating and providing direction to internal and external partners involved in clinical pharmacology study design and execution. You will champion model-based drug discovery and development and serve as a clinical pharmacology specialist to cross-functional partners.

EXAMPLE RESPONSIBILITIES:

• As a member of a drug development team, routinely provides input into product development strategies and/or research or clinical development plans for assigned products / projects.
• Typically authors the clinical pharmacology plan for one or more products in the assigned disease or therapeutic area.
• Typically leads and manages design and conduct of clinical pharmacology studies of increasing complexity, which includes responsibilities for leading the respective cross-functional study team.
• With input from others, designs clinical pharmacology study protocols, study data analysis, modeling and simulation plans.
• Leads study protocol review discussions concerning scientific and procedural aspects of pharmacology study design.
• Works with cross-functional partners and study sites to implement and monitor clinical pharmacology studies. Addresses clinical issues arising from clinical pharmacology studies.
• Directs the activities and resources for both internal and external study partners.
• Manages study timelines and resources to ensure timely and accurate execution of clinical pharmacology studies.
• Conducts PK-PD and related analyses and provides clinical pharmacology input into or otherwise authors study documentation, data analysis / management plans and scientific presentations or literature.
• Analyzes, interprets and authors documents for clinical and regulatory submissions.
• Presents project updates and other key milestone information to cross-functional partners and stakeholders.
• May support business development / due diligence activities as a clinical pharmacology expert.
• Represents clinical pharmacology for the assigned project team in interactions with regulatory agencies.
• Anticipates problems that may arise in clinical trials and develops solutions for these using precedents and original thinking.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

 

REQUIREMENTS:

 

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Basic Qualifications:

• Doctorate and 5+ years of relevant research or clinical experience OR
• Master’s and 8+ years of relevant research or clinical experience OR
• Bachelor’s and 10+ years of relevant research or clinical experience OR

 

Preferred Qualifications:

 

• Significant experience leading small cross-functional project teams in drug research or development.
• Significant experience leading study concept and protocol design, authoring clinical pharmacology development plans and modeling and simulation plans, conducting PK-PD, Pop PK-PD and related analyses, and contributing to regulatory filings, clinical publications and presentations.
• Proven effectiveness managing clinical project deliverables through matrix management.
• Relevant experience in Virology therapeutic area is strongly preferred
• Experience supporting clinical publications and presentations is strongly preferred.
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Recognized for sustained scientific excellence.
• Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies. Has significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology.
• Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
• Demonstrable ability to effectively apply business acumen to strategic scientific projects.
• Significant knowledge of PK-PD, Pop PK-PD analyses and techniques and the physiological/pharmacological aspects of drugs.
• Able to serve as a clinical pharmacology specialist in authoring clinical pharmacology protocols, development plans and modeling and simulation plans, conducting of PK-PD, Pop PK-PD and related analyses, and literature and regulatory guidelines.
• Strong communication and organizational skills.
• When needed, ability to travel.