You will typically lead multiple complex pharmacometric analyses in the Oncology, inflammation and/or Virology Therapeutic Areas, which will include analyses from studies that range from first-in human through Phase IV clinical trials. These analyses and models include, but are not limited to, population PK/PD models, disease models, quantitative systems pharmacology (QSP) models, physiologically-based PK models (PBPK) and statistical models for exposure-response analyses and model-based meta-analyses. You will be responsible for conduct or oversight as well as interpretation and reporting of the aforementioned analyses, and support of regulatory filings. You will champion model informed drug development 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.
- Leading quantitative and innovative strategies well integrated within clinical pharmacology to impact model informed drug development (MIDD) during life cycle of the molecule
- Develop and implement new pharmacometrics and state of the art quantitative pharmacology approaches to drive smarter drug development for programs
- Guide dose regimen/optimization strategies in partnership with other therapeutic area leads and clinical pharmacology leads to enable data-driven decisions
- Evaluate and apply PBPK, RWD, AI/ML and other quantitative tools as appropriate for clinical pharmacology decision making
- Represent the department and provide subject matter expertise on crossfunctional project teams
- Develop and maintain collaborative working relationship with colleagues within and outside the department
- Supervise, develop and mentor junior level scientists, fellows, interns via matrix structure in clinical pharmacology teams
- Author/review/approve modeling and simulation analysis plans and outputs, interpretation and presentation of key findings to regulators and to stakeholders as needed.
- Provide technical input for pharmacometrics reports and regulatory submissions
- Develop high quality modeling and simulation strategy and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans in collaboration with key stakeholders
- Initiate, maintain and establish relationships and agreements with contract vendors and pharmacometrics experts and consultants as needed
- Evaluate departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
- Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Understand the impact of decisions and actions on the business and consulting with colleagues and management as applicable
- Participate in and collaborating with individuals from across the business in special projects
- Develop and present training within and outside the department as needed
- 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
- PharmD or PhD in pharmaceutical sciences, pharmacology or related discipline with 8+ years' relevant pharmacometrics research or development experience.
- MS in pharmaceutical sciences, pharmacology or related discipline with 10+ years' relevant pharmacometrics research or development experience.
- Relevant experience in the Oncology and Inflammation Therapeutic Areas.
- 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 and conducting of PK-PD, Pop PK-PD and related analyses across Phase I – IV studies.
- Extensive experience contributing to literature and regulatory submissions.
- Demonstrated excellence in effectively managing multiple pharmacometrics analyses deliverables and priorities through matrix management and leadership.
Knowledge & Other Desirable Skills
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change
- Recognized for sustained scientific excellence.
- Extensive knowledge of PK-PD, Pop-PK-PD analyses and techniques and 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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