[Remote] (Associate) Medical Director - Dermatology, EMEA at Thermo Fisher Scientific

Portugal

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Medical Doctor, with a specialty in Dermatology
Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine
Previous experience in a hospital setting
Fluent in spoken and written English
Shown understanding and experience with NDA submission process
Shown understanding of regulatory guidelines for adverse event reporting
Strong communication & presentation skills and is a strong teammate

Responsibilities

Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information
Contribute to site selection, involved in 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 as required for the conduct of clinical trials
Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early; pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead
During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments; acquires other functions’ dedication to close gaps and address issues timely and effectively
Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases
Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting
Controls, handles and follows day to day activities during the course of the clinical trial to resolve any issues and answer queries
Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, 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

Skills

Dermatology

Pharmacovigilance

Clinical Trials

Medical Monitoring

Protocol Development

Safety Evaluation

Site Selection

CSR

ICF

CRF

Protocol Deviations

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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