Clinical Pharmacology Associate Director

Gilead Sciences•US - CA - offsite, CA

1d•$177,905 - $230,230

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Clinical Pharmacology Associate Director, you will handle quantitative analyses in the Oncology, Inflammation and Virology Therapeutic Areas of Gilead Sciences, Inc.. 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.

Requirements

PhD, PharmD, or equivalent degree (pharmaceutical sciences, pharmacology, or related discipline) with 2-4+ years’ relevant pharmacometrics research or development experience OR Masters or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 8+ years’ relevant pharmacometrics research or development experience OR Bachelors or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 10+ years’ relevant pharmacometrics research or development experience.

Nice To Haves

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.

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