Senior Director, Pharmacometrics

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Job description

Senior Director, Pharmacometrics
United States - RemoteUnited States - California - Foster CityUnited States - Washington - Seattle

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly

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

Senior Director, Pharmacometrics:

The Senior Director is accountable and responsible for pharmacometrics in the Oncology, inflammation and/or Virology Therapeutic Areas, which include analyses from studies that range from first-in human through Phase IV clinical trials. These analyses and models include, but are not limited to, population PK/PD models, disease models, physiologically based PK models (PBPK) and statistical models for exposure-response analyses and model-based meta-analyses.

RESPONSIBILITIES:

• Responsible for the conduct or oversight reporting of the analyses and support of regulatory filings.
• Champion model informed drug development across drug discovery and development.
• Serve as a subject matter expert for modeling and simulation to cross- functional partners.
• Play a leadership role in assessing, designing and implementing other state of the art quantitative approaches that can bring additional impact and value to multiple programs.
• Leading quantitative and innovative strategies well integrated within clinical pharmacology to impact model informed drug development (MIDD) during life cycle of the molecule
• Develop and implement new pharmacometrics and state of the art quantitative pharmacology approaches to drive smarter drug development for programs
• Guide dose regimen/optimization strategies in partnership with other therapeutic area leads and clinical pharmacology leads to enable data-driven decisions
• Evaluate and apply PBPK, RWD, AI/ML and other quantitative tools as appropriate for clinical pharmacology decision making
• Represent the department and provide subject matter expertise on cross functional project teams
• Develop and maintain collaborative working relationship with colleagues within and outside the department
• Supervise, develop and mentor junior level scientists, fellows, interns via matrix structure in clinical pharmacology teams
• Author/review/approve modeling and simulation analysis plans and outputs, interpretation and presentation of key findings to regulators and to stakeholders as needed.
• Provide technical input for pharmacometrics reports and regulatory submissions
• Develop high quality modeling and simulation strategy and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans in collaboration with key stakeholders
• Initiate, maintain and establish relationships and agreements with contract vendors and pharmacometrics experts and consultants as needed
• Evaluate departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
• Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
• Understand the impact of decisions and actions on the business and consulting with colleagues and management as applicable
• Participate in and collaborating with individuals from across the business in special projects
• Develop and present training within and outside the department as needed

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

• PharmD or PhD in pharmaceutical sciences, pharmacology or related discipline with 12+ years' relevant research or clinical experience.
• BS or MS in pharmaceutical sciences, pharmacology or related discipline with 14+ years' relevant research or clinical experience.
• Typically has extensive line management (direct reports) experience and a strong track record over successive years in hiring, managing and developing diverse top talent. Has made significant contributions to the talent pipeline and bench.
• Experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
• Demonstrated excellence leading large and complex drug development teams.

Knowledge & Other Requirements

• Recognized for sustained scientific excellence.
• Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans.
• Demonstrable ability to effectively apply business acumen to strategic scientific projects.
• Has a broad range of expertise that transcends Phase I - IV studies and the physiological/pharmacological aspects of drugs, biomarkers, pharmacogenomics, companion diagnostics and novel approaches to drug development.
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees. Able to distill complex matters into a clear business case and roadmap for execution.
• When needed, ability to travel.

The salary range for this position is: $232,220.00 - $300,520.00. 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.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 for assistance.
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