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Research Scientist – Multiple Myeloma / Translational Medicine
Pyramid Consulting, Inc
🇺🇸 United States
Hybrid
4 days ago
- PharmD
- GxP
- NGS
- Health insurance
- Pension
4 days ago
Job ID:26-29774
Pay Range: $38 - $40/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Direct and establish pharmacokinetic and pharmacodynamic (PK/PD) analysis to support clinical pharmacology for CAR T clinical trials in Multiple Myeloma.
- Serve as Biomarker lead on clinical study teams to oversee delivery of pharmacology data and documentation required for pivotal and registrational study filings.
- Review and contribute to clinical protocol design and study activities.
- Identify and establish agreements with contract research organizations (CRO) and support the transfer of Client methods.
- Collaborate with Clinical development teams including Clinical Operations, Regulatory, Clinical Data Management, and Biometrics/Stats to advance data acquisition and analyses of clinical trial data.
- Lead the resolution of clinical pharmacology/translational queries from regulatory agencies, supporting 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.
- Collaborate 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 engage with key opinion leaders in the field.
- 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.
- 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.
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Research Scientist – Multiple Myeloma / Translational Medicine · Pyramid Consulting, Inc