Director Pharmacometrics
Director Pharmacometrics
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$ 226185 - 292710
1 Vacancy
Job Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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 firstin 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 modelinformed drug development (MIDD) across drug discovery and development and serve as a subject matter expert for modeling and simulation to crossfunctional partners.
Responsibilities:
Leading quantitative and innovative strategies within clinical pharmacology to impact MIDD during the life cycle of the program
Evaluate and apply stateoftheart quantitative pharmacology approaches for clinical pharmacology decisionmaking 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 datadriven decisions
Develop highquality 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 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 8 years relevant pharmacometrics research or development experience.
Masters or equivalent degree in engineering pharmaceutical sciences pharmacology or related discipline with 10 years relevant pharmacometrics research or development experience. Bachelors 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 crossfunctional project/program teams in life sciences.
Extensive experience in pharmacometrics leading and authoring modeling and simulation plans and having responsibility for the scientific of 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 quantitative analyses as well as the physiological/pharmacological aspects of .
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.
For additional benefits information visit:
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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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Required Experience:
Director
Employment Type
Full-Time
