Research Scientist, Biomarker Sciences I

Job Description

Job 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.

Duties and 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.

Education & Experience:

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

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.