Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (Hybrid)

, PA, United States

Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (Hybrid) page is loaded Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (Hybrid) Apply locations USA - New Jersey - Rahway USA - Pennsylvania - Upper Gwynedd USA - Massachusetts - Boston (MA Parcel B Laboratory) USA - California - San Francisco time type Full time posted on Posted Yesterday job requisition id R277875 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, with or without PharmD, or equivalent degree 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 decisions through application of model-based approaches.

Proficiency in R, NONMEM or other similar programing language.

Professional working proficiency in written and verbal communication.

EBRG#

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Expected salary range:

$181,600.00 - $285,800.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here .

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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:

Similar Jobs (1) Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (Remote) locations 4 Locations time type Full time posted on Posted Yesterday

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