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(Associate) Medical Director - Neurology

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Thermo Fisher Scientific

14d ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    Healthcare
  • Milan

AI generated summary

  • You must have an MD/MB/BS, clinical neurology experience, pharmaceutical industry expertise, NDA submission knowledge, and strong communication skills. Fluency in English is essential.
  • You will lead medical aspects of clinical trials, develop protocols, ensure subject safety, monitor studies, liaise with stakeholders, train site staff, and ensure compliance with SOPs and GCP.

Requirements

  • MD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Neurology patients in hospital practice.
  • Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important
  • Is 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, part of Thermo Fisher Scientific 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

FAQs

What are the working hours for the (Associate) Medical Director - Neurology position?

The working hours are standard, Monday to Friday.

What is the primary responsibility of the (Associate) Medical Director?

The primary responsibility is to provide medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department.

What educational background is required for this position?

An MD, MB/BS, or equivalent degree with strong medical knowledge and clinical experience running Neurology patients in hospital practice is required.

Is experience in the pharmaceutical industry necessary for this role?

Yes, significant experience within the pharmaceutical industry, clinical trials, and pharmaceutical medicine is critically important.

What language proficiency is required for this position?

Fluency in spoken and written English is required.

Will the (Associate) Medical Director interact with external stakeholders?

Yes, the position requires interaction with investigators, IRBs, Health Authorities, and participation in study executive and independent safety committee meetings.

What are the environmental conditions for this job?

The position is office-based, primarily in an office environment.

Is experience with NDA submission processes important for this role?

Yes, a shown understanding and experience with the NDA submission process is important.

What skills are highlighted as essential for this job?

Strong communication and presentation skills, as well as being a strong teammate, are essential.

Are there opportunities for professional development within Thermo Fisher Scientific?

Yes, Thermo Fisher Scientific provides teams with the resources needed to achieve individual career goals while contributing to meaningful work.

What does Thermo Fisher Scientific value in its employees?

Thermo Fisher Scientific values integrity, intensity, innovation, and involvement in its employees, promoting diverse experiences, backgrounds, and perspectives.

How can I apply for this position?

You can apply for the position at http://jobs.thermofisher.com.

Does Thermo Fisher Scientific have a non-discrimination policy?

Yes, Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.