[Remote] Senior Medical Director, EMEA at Thermo Fisher Scientific

Belgium

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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

MD degree with Board-certification in a therapeutic area
A minimum of 5 years of clinical drug development experience in either a CRO or pharma
Desirable: Experience in the therapy areas Infectious Disease and Neurology, but not limited to these
Demonstration and commitment to vigilant proactive problem solving
Excellent leadership abilities
Able to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical

Responsibilities

Provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process
Line management responsibilities to medical team members in EMEA
Oversight and development of the medical team and provides strategic leadership and business direction within the Pharmacovigilance (PV) department and across other functional areas requiring medical oversight
Design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations
Leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives and the documentation of study results
Acts as a clinical/medical representative in meetings with external stakeholders (e.g. collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.g. vendors, consultants, etc.) and other external audiences as needed
Provides medical content and leadership of clinical studies
Provides strategic leadership for development of the global medical team in EMEA
Medical Monitoring of clinical studies
Establishes and approves scientific methods underlying the design and implementation of clinical protocols
Ensures study participant safety
Regularly reviews adverse event, laboratory and other clinical data, ensuring reporting is done on a timely basis
Collaborates with the study executives and independent safety committees when needed
Demonstrates medical leadership on the therapeutic areas and clinical trials
Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials
Interprets, summarizes and documents clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required
Collaborates with leading academic medical centers
Ensures study compliance by understanding and applying all relevant SOPs and GCPs
Participates in long range strategic planning

Skills

Clinical Drug Development

Pharmacovigilance

GCP Regulations

Clinical Development Plans

Clinical Trials

Protocol Design

Study Analysis

Medical Leadership

Line Management

KOL Engagement

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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