[Hiring] Research Scientist PI – Biomarker, client dedicated @Thermo Fisher Scientific

Work Schedule

Environmental Conditions

Job Description

This is a fully remote role based in the UK supporting one of our key customers.

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 4+ 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
• OR
• Bachelor's Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 8+ 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.