Senior Director, Pharmacometrics (Hybrid)

Job Description
Senior Directors in the Pharmacometrics group within the department of Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on a continuous basis by evaluating and incorporating M&S tools in decision making and drive pipeline impact.
Senior Directors provide strategic pharmacometrics leadership and oversight, both supervising the work of other scientists and a portfolio of projects and leading pharmacometrics efforts on drug development programs. Senior Directors are expected to have or be developing expertise in several areas, including:

• Leverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas, modalities and stages of drug discovery/development to independently provide day-to-day coaching/guidance to individual contributors
• Responsible for achieving results via others on major program drivers by implementing novel quantitative approaches (translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses) that seek to improve cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programs
• Serving as an expert Pharmacometrics representative for QP2 on drug/vaccine development teams
• Framing critical drug development questions for optimizing model-based development
• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings
• Overseeing a group of scientists (in a scientific and/or supervisory role)
• Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities
• May provide functional representation on committees, task forces or initiatives spanning beyond QP2
• Provides review and scientific input on reports and regulatory documents at all stages of development
• Manages and initiates external collaborations with world leading experts to develop new methodologies
• Fosters collaboration within QP2 to achieve results, remove barriers on portfolio or scientific priorities

Senior Directorsin the Pharmacometrics group within QP2 are skilled pharmacometricians, with a strong, integrated understanding of the strategic elements of drug discovery and development, and lead the combined efforts of QP2 and the wider Translational Medicine (TMED) organization. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Senior Directors demonstrate outstanding leadership and communication skills. They collaborate within QP2 and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.
Required:

• (a Ph.D. or equivalent degree with at least 10 years of experience) OR (a PharmD or equivalent degree with at least 12 years of experience) OR (an MS or equivalent degree with at least 14 years of experience), where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.
• Educational background in pharmacometrics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
• Deep expertise in pharmacometrics (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling) with ability to understand how MIDD can drive portfolio and regulatory decisions.
• Deep knowledge of drug development, pharmacokinetics and pharmacology and basic science skills required
• Drug development expertise agnostic of therapeutic area, including a record of both internal and external impact in driving model-informed drug development strategies across programs
• Proficiency in state-of-the-art modeling approaches (for e.g., NONMEM, Bayesian estimation, MBMA, CTS, QSP)
• Demonstrated ability to apply appropriate FDA, EMA and other/ICH guidelines in the application of predictive model-based approaches in the design of development plans and study design
• Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings.

Preferred:

• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry.
• Extensive experience in developing quantitative strategies for impacting pipeline decisions
• Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
• Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists
• Emerging leader in the field of Pharmacometrics with a track record of sustained external visibility, through publications, presentations and/or involvement in professional organizations
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
• Communication Skills: demonstrates ability to effectively present complex data, development plans and strategies to various audiences in both verbal and written form, steer and influence interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise.

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Expected salary range:
$200,200.00 - $315,100.00
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Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Required Skills:
Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship Management
Preferred Skills:
Biological Sciences, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs, Computational Biology, Drug Development, Drug Discovery Process, FDA Regulations, Leadership, Mathematics, Pharmaceutical Sciences, Pharmacodynamics, Pharmacokinetics, Pharmacology, Pharmacovigilance, Portfolio Management, Predictive Modeling, Quantitative Research, Regulatory Documents, Statistics, Strategic Data Analysis, Strategic Planning, Therapeutics