Translational Scientist

Job Description

Summary

The Research Scientist will support biomarker and translational strategy for the clinical development of Client’s 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 Client 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

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)