Research Scientist Multiple Myeloma / Translational Medicine

Pyramid-Consulting,-Inc.; Santa Monica (CA); On-site; USD 52,000 - 55,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid sick leave

Job summary

Pyramid Consulting, Inc. is seeking a Research Scientist for an onsite role in Santa Monica, CA. The position focuses on translational medicine for Multiple Myeloma, with a 6+ month contract and potential extension.

The candidate will lead PK/PD analyses and biomarker efforts within CAR T programs, interfacing with cross-functional teams. The ideal candidate will have an advanced science degree and extensive experience in oncology translational medicine, regulatory interactions, and data

Qualifications

• Advanced scientific degree (MD/PhD/PharmD) or equivalent with relevant industry experience.
• Strong background in cancer immunotherapy and oncology.
• Experience with regulatory filings and clinical study support.
• Familiarity with biomarker discovery and translational research.
• Proficient data presentation and cross-functional communication.

Responsibilities

• Direct PK/PD analysis to support clinical pharmacology for CAR T trials in Multiple Myeloma.
• Lead biomarker workstreams on clinical study teams and oversee data delivery for filings.
• Review and contribute to clinical protocol design and study activities.
• Identify and establish CRO agreements and transfer methods.
• Collaborate with Clinical Development, Regulatory, CDM, and Biometrics to advance data analyses.
• Lead responses to regulatory queries and support regulatory filings.
• Prepare data packages for publication with medical writers or submissions to agencies.
• Collaborate on translational studies for deeper tumor biology analyses.
• Engage with external scientists and key opinion leaders.

Skills

Cancer immunotherapy

Biomarker operations

Regulatory filings

Data presentation

Cross-functional collaboration

Education

MD/PhD/PharmD

Master's degree

Bachelor's degree

Tools

NGS-based profiling

Bioanalytical assay development

GxP environment

Job description

Immediate need for a talented Research Scientist – Multiple Myeloma / Translational Medicine. This is a 06+ Months Contract opportunity with long-term potential and is located in Santa Monica CA (Onsite).

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.

Key Requirements and Technology 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.
• 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.

Our client is a leading Biopharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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