Research Scientist, Multiple Myeloma – Translational Medicine

Job title: Research Scientist, Multiple Myeloma – Translational Medicine

Job Description

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

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter directly so that we can explore the appropriate arrangements.