Director, Quantitative Pharmacology Lead - Pharmacometrics
The Director, Quantitative Pharmacology (QP) position sits within Alexion’s Clinical Pharmacology and Safety Sciences (CPSS) organization. The QP Lead is responsible for representing pharmacometrics leadership, within a therapeutic area (TA), and partnering with Non-Clinical and Clinical Pharmacology (NCCP) Leads to align on model-informed drug discovery and development (MIDD) strategies throughout the drug development process. Responsibilities include team communication of strategies, analyses, and logistics; application of expert technical knowledge; and management of internal and external resources to complete deliverables required to support application for approval of new medicines, in rare diseases.
Overall, this key role is an integral part of ensuring a quantitative focus within Alexion by contributing to the ongoing improvement in the strategic use of pharmacometric tools and approaches across the rare disease space.
- Develop Modeling & Simulation (M&S) strategies and identify opportunities where MIDD can assist decision making at critical milestones including:
- Application of model-based approaches preclinically to inform FIH dose regimens.
- Exposure-response analyses supporting dose selection before and after POC, and quantitative assessment of probability of success for the program using M&S
- Make dose selection recommendations for Phase II and III clinical trials based on M&S by integrating PK/PD, efficacy, and safety data analyses.
- Contribute to the design of late-stage clinical trials by providing clinical trial simulations under various potential scenarios
- Conduct quantitative PK/PD assessments to evaluate due diligence opportunities.
- Determine resourcing for M&S work
- Initiate, lead, and oversee outsourced M&S activities.
- Manage internal QP resource as available
- Plan and execute quantitative analyses that are fully aligned with preclinical and clinical plans. Analyses may include (but are not limited to):
- Population PK, PK/PD, exposure response, disease progression, PBPK, and QSP.
- Ensure timely delivery of analysis results and documents including:
- Modeling and simulation analysis plan, summary report, and submission PK/PD report
- Contribute to clinical development plan, pediatric investigational plan, briefing book, and submission document.
- Contribute to strengthening Alexion’s internal M&S capability by
- Evaluating and introducing new M&S tools and computing platforms.
- Leading projects of internal interest, e.g., building quantitative systems biology/pharmacology (QSP) to support the activities from early discovery to FIH and beyond
- Mentor QP modelers and scientists as needed.
- May have people manager responsibilities depending on group needs and incumbent’s career goals.
- A total of 10+ years pharmaceutical industry experience in Pharmacometrics, QSP, PKPD M&S, or other mathematical model-based disciplines.
- Excellent written and verbal communication skills; and strong leadership and people interaction skills.
- Extensive experience applying pharmacometric approaches across preclinical and clinical phases of drug development. Proven record of applying pharmacometrics methodologies in a drug R&D context is a plus.
- Proven record of contributions to INDs, NDAs and BLAs, and technical and practical knowledge of global regulations and regulatory guidance documents is preferred.
- Proven record of simultaneously managing and completing multiple complex projects independently and through direct reports.
- Published author of M&S work, and a recognized expert.
- Expert knowledge and hands-on experience in NONMEM or Matlab, R, S+, and/or SAS.
- Additional experience with Monolix, Phoenix/nlme, SAS, Python, Julia, or other mixed effects software is preferred.
- Experience applying pharmacometric approaches in hematology, nephrology, metabolic, and neurological disorders, and rare diseases is preferred.
- Knowledge of managing departmental budgets and experience managing M&S vendors is preferred.
- Experience scoping and executing due diligence activities is preferred.
A PhD degree or equivalent degree or years of experience in a quantitative sciences field, background in engineering, mathematics, statistics, clinical pharmacology, or health sciences-related field is preferred.
This role has an expectation of working in the office 3 days a week. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.