Description
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description
You will typically work on 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 be a team contributor for modeling and simulation to cross-functional partners. You will also play a key 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.
- Collaborate 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.
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.
- 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.
- 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.
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.
