Research Scientist, Multiple Myeloma – Translational Medicine

Summary

The Research Scientist will support biomarker and translational strategy for the clinical development of Kites chimeric antigen receptor (CAR-T) programs in Multiple Myeloma. As a member of the Translational Medicine team, you will be at the intersection of Research and Clinical Development, providing valuable insight into the function of CAR-T cells in patients and the development of potential prognostic tools. Regulatory filing experience and a demonstrated ability to facilitate clinical trial execution, synthesize scientific data, communicate key findings cross-functionally is required.

Key Responsibilities:

* Directs and establishes pharmacokinetic and pharmacodynamic (PK/PD) analysis to support clinical pharmacology for CAR T clinical trials in Multiple Myeloma

* Serves as Biomarker lead on clinical study teams to oversee delivery of pharmacology data and documentation required for pivotal and registrational study filings

* Reviews and contributes to clinical protocol design and study activities

* Identify and establish agreements with contract research organizations (CRO) and support the transfer of novel methods

* Collaborates with Clinical development teams including Clinical Operations, Regulatory, Clinical Data Management and Biometrics/Stats to advance data acquisition and analyses of clinical trial data

* Leads the resolution of clinical pharmacology/translational queries from regulatory agencies, supports writing and reviewing responses to regulatory queries.

* Support the preparation of data packages for publication with medical writers, presentation and/or submission to regulatory agencies

* Collaborates with Translational Medicine, Bioinformatics and Statistical teams for exploratory biomarker correlative studies and deeper analysis of tumor biology and CAR T functionality

* Contribute to external scientific discussions/research collaborations and publications and engagement with key opinion leaders in the field

Education Level

Advanced scientific degree (i.e. MD, PharmD, PhD) and 3+ years in industry

OR

Master’s Degree and 5+ years of scientific experience

OR

Bachelor’s Degree and 7+ years of scientific experience

Experience

Preferred Qualifications:

* Strong background in cancer immunotherapy, immunology and/or oncology with experience focusing on Multiple Myeloma

* Prior experience in Regulatory filings

* In-depth understanding of multiple myeloma, knowledge of clinical landscape, evolving therapy, competitive scenarios

* Strong understanding of clinical, translational, and mechanistic data

* Familiarity and experience with clinical and biomarker operations

* Understanding of early or late-stage drug and translational development process; including clinical trial experience in industry or academia

* Familiarity with bioanalytical assay development and validation in a GxP environment

* Experience working with engineered T cells, immunophenotyping, and NGS-based approaches to profile the function of tumor and immune cells

* Comfortable in a matrixed and fast-paced company environment and able to adapt to changing priorities

* Strong collaboration, excellent interpersonal and communication skills

* Proficient with data presentations to communicate to a diverse cross-functional audience

* Maintain a high degree of accuracy and attention to detail

* Ph.D. degree in biology-related field (immunology, cancer biology, bioinformatics or a closely related field)

Pay ranges between 40-47/hr based on experience