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

North Carolina, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical Research, HealthcareIndustries

Requirements

Medical Doctor or equivalent degree required. Board certification(s) preferred
Specialty education (e.g., residency/fellowship) required in pediatrics, accompanied by patient treatment and/or research experience
1-3 years of industry experience required in clinical development or medical monitoring in a Pharmaceutical, Biotech, or CRO organization
Pediatricians with expertise in Pediatric Neurology, Rheumatology, or Rare Disease highly preferred
Excellent English, both written and spoken
Ability to travel (10-20% range, international may be required)
Ideal location in Eastern or Central Time Zone (fully remote position)

Responsibilities

Provide medical leadership to study teams, including creating clinical trial protocols incorporating the latest scientific information
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
Perform real-time medical monitoring of clinical studies to ensure medical validity of primary endpoints, study subject safety, and early identification/escalation of medical issues in consultation with the Global Medical Indication Lead
Interpret clinical trial data for regulatory documents (e.g., CSR, INDs, Annual Reports, NDAs, MAAs), manuscripts, and publications in consultation with the Indication Lead
Serve as medical point of contact for internal and external stakeholders: interact with investigators, answer IRB and Health Authority questions, prepare/present to study executive and safety committees, provide medical training at Investigator meetings, and train CRAs in new indications
Ensure study compliance for all medical aspects by understanding and applying relevant SOPs and GCP
Collaborate closely with cross-functional study team members to ensure medical risks, issues, and results are clear to all parties
If multiple physicians on protocol, as primus inter pares, harmonize answers to site/IRB/RA questions, eligibility, and protocol deviation decisions across medics

Skills

Key technologies and capabilities for this role

Clinical TrialsMedical LeadershipProtocol DevelopmentStudy ProtocolsClinical Study ReportsInformed Consent FormsCase Report FormsProtocol DeviationsSite SelectionPediatrics

Questions & Answers

Common questions about this position

Is this position remote?

Yes, this position is fully remote and benefit eligible, with ideal candidate location in the Eastern or Central Time Zone and travel required in a 10-20% range (international may be required).

What are the key responsibilities of this role?

The role involves providing medical leadership to study teams, creating clinical trial protocols, real-time medical monitoring of studies, interpreting clinical data for regulatory documents, and serving as the medical point of contact for stakeholders.

What is the work schedule for this position?

The work schedule is standard Monday through Friday.

Does this role involve teamwork?

Yes, the role requires providing clear medical leadership in the Study team and working in close collaboration with other members of the cross-functional team.

What makes a strong candidate for this Medical Director role?

A strong candidate will have expertise in clinical trials, particularly in pediatrics, with the ability to provide medical leadership, monitor studies in real-time, interpret data for regulatory submissions, and collaborate effectively with cross-functional teams and stakeholders.

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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