Logo of Huzzle

(Associate) Medical Director - Neurology

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

AI generated summary

  • You must have an MD or equivalent, strong neurology clinical experience, industry background, NDA submission knowledge, and excellent communication skills.
  • You will lead medical aspects of clinical trials, ensuring protocol adherence, monitoring safety, liaising with stakeholders, and providing training while addressing study issues promptly.

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 is the work schedule for this position?

The work schedule is standard Monday through Friday.

What is the primary focus of the (Associate) Medical Director role?

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

What qualifications are required for this position?

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

Is experience in the pharmaceutical industry necessary?

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

What language proficiency is expected for this role?

Fluency in spoken and written English is required.

Will travel be required for this position?

While the job description does not explicitly mention travel, interaction with investigators and participation in meetings may involve occasional travel.

What types of documents will the (Associate) Medical Director be involved with?

The role involves the review and approval of clinical trial protocols, amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and other clinical documents.

Are there opportunities for career development in this role?

Yes, Thermo Fisher Scientific provides teams with the resources needed to achieve individual career goals, promoting career development.

How does Thermo Fisher Scientific prioritize diversity and inclusion?

Thermo Fisher Scientific values diverse experiences, backgrounds, and perspectives, and is committed to being an EEO/Affirmative Action Employer.

What is the company's mission?

The company's mission is to enable customers to make the world healthier, cleaner, and safer.

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.