Associate Medical Director/Principal Investigator - Clinical Research at Thermo Fisher Scientific

Las Vegas, Nevada, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Valid medical license (inferred from role as Physician and FDA Form 1572 responsibilities)
Experience or qualifications suitable for role as Associate Medical Director/Principal Investigator in clinical research
Ability to work full-time office-based position (Mon-Fri standard schedule) at Las Vegas Clinical Research Unit
Compliance with Corporate Practice of Medicine (CPOM) Laws in NV
Availability for weekend call coverage (rotated through investigator team)

Responsibilities

Serve as physician investigator on assigned clinical trials, providing medical oversight for protocols and clients
Ensure protocols are conducted under applicable laws, regulations, and ICH-GCP guidelines
Consult with clients and provide scientific and medical insight for protocols
Research compounds for subject safety
Evaluate and sign off on medical data, completed case report forms (CRFs), and final clinical study reports (CSRs)
Foster relationships with clients and support operational and business development staff
Support local team in quality initiatives and regulatory requirements at Phase 1 32-bed facility
Review protocols for scientific, logistical, and safety feasibility
Adhere to client directives and study protocols
Perform duties as described in FDA Form 1572, including informed consent, screening examinations, and clinical management of safety issues
Present first-in-human and high-risk trials to Human Safety Committee (HSC) and develop risk management plans (RMPs)
Provide training on assigned studies
Discuss medical concerns with investigators and clients using proper medical judgment
Provide medical consultation to team members and answer study-related medical questions
Communicate with associates and clients to ensure procedures are followed; deviate from protocol only for emergent safety needs
Monitor, evaluate, and act on safety variables (adverse events, lab/ECG abnormalities, medical status changes, unblinding requests)
Assess adverse events for causality and study drug relationship; determine clinical significance of abnormalities
Contribute to departmental process improvement initiatives

Skills

Clinical Trials

ICH-GCP

Principal Investigator

Medical Oversight

Protocol Review

CRF

CSR

Phase 1 Studies

Regulatory Compliance

Physician

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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