Research Scientist PI – Biomarker

Work Schedule Standard (Mon-Fri) Environmental Conditions Office This is a fully remote role supporting one of our key customers. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. The Research Scientist acts as the sponsor representative/study monitor for one or more studies and supports the biomarker discovery and validation to support clinical trials. Key responsibilities:

• Coordinates and oversees exploratory sample shipment and analysis to guarantee consistency and reliability in results
• Reviews and verifies exploratory biomarker data to ensure completeness and support data transfer to Study Sponsor.
• Liaises with specialty laboratories to facilitate communication, address issues, and ensure alignment on study objectives and timelines
• Critically reviews sample analysis plan
• Reports and maintains comprehensive documentation of all monitoring activities, including assay performance data and any deviations.
• Identifies potential risks related to sample analysis and implement mitigation strategies
• Regularly updates Study Sponsor team members on progress, challenges, and outcomes related to biomarker sample analysis activities.
• Any other tasks as deem appropriate for the conduct of the exploratory biomarker oversight

Education and Experience:

• PhD in Immunology or Molecular Biology and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 3+ years
• OR
• Master’s Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 6+ years

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:

• Experience in managing outsourced activities at external vendors required
• Strong working knowledge of several classes of biomarker techniques and analytical platforms (e.g., qPCR, NGS, IHC, FISH, MRI/PET/CT imaging, flow cytometry, LS/MS, ligand binding assays, enzymatic assays, etc.) required
• Previous experience developing exploratory and/or diagnostic biomarkers assays including study design, method validation, and reporting required
• Expert knowledge of biomarker analytical data analysis and reporting required
• Strong working knowledge of GCP/GCLP guidelines and other current global regulations required
• Strong working knowledge of assay validation requirements for Phase I/II clinical trials required
• Previous experience characterizing the pharmacological effects using biomarker assays
• Previous experience defining the context of use (COU) and data analysis strategy for biomarkers
• Previous experience translating biomarker assay applicability to all clinical trial phases
• Extensive experience collaborating with independent stakeholders including escalation, risk management, and confidentiality management

Working Environment: Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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