Thermo Fisher Scientific

FSP Clinical Research medical Advisor, EMEA

Bulgaria

Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical Research ServicesIndustries

Requirements

The candidate should possess expertise in clinical research within designated therapeutic areas such as Cardio-Renal-Metabolic/Immunology/Neuroscience. They must provide clinical strategic and tactical leadership as the Country Clinical Development representative, bridging study site operations and Medical Affairs. The role requires gathering, informing, and acting on clinical/medical/scientific insights to optimize trial implementation, drive investigator identification, and overcome recruitment hurdles. Collaboration with country functions like clinical trial operations and Medical Affairs is essential for successful trial allocation, start-up, recruitment, and mitigation plan development. The individual must validate study designs, make feasibility decisions based on medical practice and competitive analysis, and provide clinical/medical expertise for IRB/EC interactions and external expert engagements. They will develop clinical/medical trial plans considering the broader ecosystem and support Sponsor Stakeholders as the scientific/clinical/medical expert. Responsibilities include adherence to safety standards, clinical data quality, and providing scientific/clinical/medical support for safety issues. Travel as needed is also a requirement.

Responsibilities

The FSP Clinical Research medical Advisor will be accountable for all country clinical/medical aspects of development and prioritized research programs/trials, providing clinical strategic and tactical leadership. They will gather, inform, and act on clinical/medical/scientific insights for clinical trial concept sheets, protocols, and Informed Consent Forms to optimize implementation. The role involves driving the identification and involvement of qualified investigators with recruitment potential, identifying recruitment hurdles, and implementing activities to overcome them. The advisor will collaborate with other country functions to ensure fast clinical trial start-up, timely recruitment, early identification of potential delays, and the development and implementation of mitigation plans. Key duties include validating study designs, making final decisions on clinical/medical trial feasibility, contributing to the scientific/clinical/medical aspects of the start-up phase, and providing clinical/medical expertise to clinical trial operations team members and sites for IRB/EC interactions. They will also provide scientific/clinical/medical expertise during interactions with country/cluster external experts, develop clinical/medical trial plans considering the broader ecosystem, and support Sponsor Stakeholders as the scientific/clinical/medical expert. Additionally, the advisor will gather and act on insights from investigators, medical experts, patients, and payers with stakeholders to optimize trial implementation and carry accountability for adherence to safety standards and clinical data quality for the country/cluster.

Skills

Clinical Research
Medical Affairs
Clinical Trials
Protocol Development
Investigator Engagement
Recruitment Strategy
Therapeutic Areas
Cardio-Renal-Metabolic
Immunology
Neuroscience
Scientific Insights
Informed Consent Forms

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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