(Associate) Medical Director - Neurology

buscojobs España; Ourense; Presencial; EUR 80.000 - 120.000; Jornada completa

Descripción de la vacante

A leading company in clinical research is looking for an Associate Medical Director to guide clinical trials and ensure compliance and safety. You will lead study teams, develop trial protocols, and interact with various stakeholders. A medical degree and extensive experience in the pharmaceutical industry are essential for this impactful role.

Formación

• Fluency in spoken and written English required.
• Experience in clinical trials and pharmaceutical medicine.
• Knowledge of NDA submission process and regulatory guidelines.

Responsabilidades

• Provide medical leadership and create clinical trial protocols.
• Ensure medical validity and subject safety during clinical studies.
• Serve as chief liaison between sponsor and PPD.

Conocimientos

Medical knowledge

Communication

Teamwork

Educación

MD, MB / BS or equivalent

Descripción del empleo

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Discover Impactful Work :

The (Associate) Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department.

A day in the Life :

• 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 as 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, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Acquire other functions’ dedication to close gaps and address issues timely and effectively. Serve as chief liaison between sponsor and all PPD, part of Thermo Fisher Scientific internal departments performing the required tasks during all study phases. Educate Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting. Control, handle and follow 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.

Education :

• MD, MB / BS or equivalent degree and strong medical knowledge, shown clinical experience running Neurology patients in hospital practice.

Knowledge, Skills, Abilities :

• Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important.
• Fluency in spoken and written English.
• Understanding and experience with NDA submission process.
• Understanding of regulatory guidelines for adverse event reporting.
• Strong communication & presentation skills and is a strong teammate.

Apply today!

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

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