Director, Pharmacometrics

Gilead; United States; Remote; USD 205,000 - 267,000; Full time

Job summary

An established industry player is seeking a Director of Pharmacometrics to lead innovative quantitative analyses across drug development stages. This critical role involves championing model-informed drug development and collaborating with cross-functional teams to drive impactful decisions. The ideal candidate will possess significant experience in pharmacometrics and a strong foundation in pharmacology, with the ability to communicate effectively at all organizational levels. Join a forward-thinking company dedicated to tackling the world's biggest health challenges and make a meaningful impact in the lives of patients globally.

Benefits

Company-sponsored medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Discretionary annual bonus

Stock-based long-term incentives

Qualifications

• 8+ years of relevant pharmacometrics research or development experience.
• Experience leading cross-functional teams in life sciences.

Responsibilities

• Lead quantitative analyses in Oncology, Inflammation, and Virology.
• Guide dose regimen strategies and ensure adherence to timelines.

Skills

Quantitative Analysis

Pharmacology

Model-Informed Drug Development (MIDD)

Communication Skills

Mathematics

Leadership

Education

PhD in Engineering or Pharmaceutical Sciences

Masters in Engineering or Pharmaceutical Sciences

Bachelors in Engineering or Pharmaceutical Sciences

Job description

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

Director, Pharmacometrics You will typically lead quantitative analyses in the Oncology, Inflammation and Virology Therapeutic Areas. These analyses will include all stages of drug development from first-in human through Phase IV clinical trials. You will be responsible for the conduct as well as interpretation and reporting of the analyses, and support of regulatory filings. You will champion model-informed drug development (MIDD) across drug discovery and development and serve as a subject matter expert for modeling and simulation to cross-functional partners.
Responsibilities:

• Leading quantitative and innovative strategies within clinical pharmacology to impact MIDD during the life cycle of the program
• Evaluate and apply state-of-the-art quantitative pharmacology approaches for clinical pharmacology decision-making and for global regulatory submissions, including INDs, IBs, NDAs, BLAs, MAAs, and pediatric plans in collaboration with key stakeholders.
• Evaluate and apply strategy and content as appropriate.
• Guide dose regimen/optimization strategies in partnership with other therapeutic area leads and clinical pharmacology leads to enable data-driven decisions
• Develop high-quality modeling and simulation strategy and content: author/review/approve modeling and simulation analysis plans and outputs, interpretation, and presentation of key findings to regulators and to stakeholders as needed.
• Ensure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
• Develop and present training within and outside the department as needed

Basic Requirements:

• PhD or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 8+ years’ relevant pharmacometrics research or development experience OR
• Masters or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 10+ years’ relevant pharmacometrics research or development experience OR
• Bachelors or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 12+ years’ relevant pharmacometrics research or development experience.

Preferred Requirements:

• Significant experience working on, with, and leading cross-functional project/program teams in life sciences.
• Extensive experience in pharmacometrics leading and authoring modeling and simulation plans and having responsibility for the scientific execution of related analyses across Phase I – IV studies.
• Demonstrated excellence in effectively managing multiple pharmacometrics analyses deliverables and priorities through matrix management and leadership.
• Relevant experience in the Oncology, Virology, and/or Inflammation Therapeutic Areas.
• Proficiency in mathematics
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change
• Recognized for sustained scientific excellence.
• Extensive knowledge of quantitative analyses as well as the physiological/pharmacological aspects of drugs.
• Strong communication and organizational skills.
• Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams and executives.
• When needed, ability to travel.

The salary range for this position is: $205,615.00 - $266,090.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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