Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (Remote)
USA - New Jersey - Rahway
Job Description
Role and Responsibilities:
We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Director. QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. Directors demonstrate outstanding leadership and communication skills. They collaborate within QP2-IO 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.
Primary Responsibilities:
Serving as an expert representative for QP2 -IO on Oncology development teams.
Framing critical questions and strategy for optimizing model-based analyses on programs.
Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling into programs, comparator modeling, thereby strengthening our pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.
Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.
Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.
Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities.
Minimum education required:
Ph.D. with at least four years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.
Masters or PharmD, with at least six years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.
Required Experience:
Demonstrated impactful experience with applications of pharmacometrics methods.
Experience in IND, NDA and other submissions to global regulatory agencies.
Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development …
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Hybrid Hybrid work model
Benefits/PerksFlexible work arrangements Hybrid work Hybrid work model Insurance Meetings Paid holidays Retirement benefits Sick Days Vacation
Tasks- Author regulatory documents
- Business intelligence
- Collaborate with cross functional teams
- Collaboration
- Communication
- Data Analysis
- Data modeling
- Data visualization
- Innovation
- Leadership
- Machine Learning
- Mentoring
- Mentor junior staff
- Problem solving
- Project management
- Relationship Management
- Software development
Analysis Biologics Biomedical Engineering Biostatistics Business Intelligence Business Operations Chemical Engineering Clinical Development Clinical Pharmacology Clinical Trial Design Collaboration Communication Data Data analysis Database design Data engineering Data Science Data Visualization Decision making Design Drug Development Engineering Experimental Design Innovation Leadership Machine Learning Management Manufacturing Mathematical problem solving Mathematics Mentoring Oncology Pharmacology PK/PD Project Management R Relationship Management Research Small Molecules Software Development Statistics
Experience4 years
EducationBiomedical Engineering Biostatistics Business Data Science Engineering Management Master's Mathematics Oncology Pharmacology Pharm.D Ph.D. Science Statistics
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9