[Remote] Medical Director/Clinical Trial Physician - Pediatrics at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Medical Doctor or equivalent degree required
Board certification(s) are preferred
Specialty education in pediatrics (residency/fellowship) required
Patient treatment and/or research experience required
1-3 years of industry experience in clinical development or medical monitoring (Pharmaceutical, Biotech or CRO)
Pediatricians with expertise in Pediatric Neurology, Rheumatology or Rare Disease are highly preferred
Excellent English, both written and spoken
Ability to travel (10-20%, international maybe required)
Understanding and experience with NDAs

Responsibilities

Provide medical leadership to the study teams, including creating clinical trial protocols
Contribute to site selection, review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents
Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety
Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead
Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications
Medical point of contact for all internal and external stakeholders: Interact with the investigators, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable
Medical training of site staff at Investigator meetings
CRA training in new indications
Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
Ensure harmonization of answers to questions from sites /IRBs RAs, eligibility and protocol deviation decisions

Skills

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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