Director, Quantitative Pharmacology and Pharmacometrics – Oncology

Job Description

We are seeking an experienced talented scientist to join theQuantitative 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 and comparator modeling.

• Strategizing and executing modeling of tumor size and survival. A

• 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 seven years of pharmaceutical drug development experience relating to: PKPD pharmacometrics mathematics statistics/ biostatistics or chemical/biomedical engineering.

• Masters or PharmD with at least nine 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 impact 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/interpretationand 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 NONMEMMATLAB Monolix or other modeling software.

• Professional working proficiency in written and verbal communication.

The remote position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable the position will be hybrid. Please note that standard commute is (less than) <50 miles.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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