Senior Director, Quantitative Systems Pharmacology - Pharmacometrics

Senior Director, Quantitative Systems Pharmacology - Pharmacometrics
United States - California - Foster City

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 #CreatingPossible

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Job Description


You will typically lead multiple complex systems pharmacology 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. You will also 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.

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 systems 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 QSP, PBPK 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.
  
• Supervise, develop and mentor junior level scientists, fellows, and interns via matrix structure in clinical pharmacology teams.
  
• 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
  

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 or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 12+ years' relevant pharmacometrics research or development experience.
  
• Relevant experience in the Oncology, Virology, and/or Inflammation Therapeutic Areas.
  
• Significant experience working on, with, and leading cross-functional project/program teams in life sciences.
  
• Extensive experience in QSP pharmacometrics leading and authoring modeling and simulation plans and having responsibility for the scientific execution of systems pharmacology related analyses across Phase I - IV studies.
  
• Demonstrated excellence in effectively managing multiple pharmacometrics analyses deliverables and priorities through matrix management and leadership.
  

Knowledge & Other Desirable Skills

• 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 systems pharmacology models and techniques 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.
  

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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 careers@gilead.com for assistance.

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