(Associate) Medical Director - Neurology

CRA School; Madrid; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

An established industry player is seeking an (Associate) Medical Director to lead medical support for clinical trials in the Pharmacovigilance department. This role involves creating clinical trial protocols, ensuring subject safety, and collaborating with cross-functional teams. The ideal candidate will have an MD or equivalent degree, significant experience in clinical trials, and strong communication skills. Join a forward-thinking organization dedicated to improving health outcomes globally, where your contributions will make a meaningful impact on patients' lives.

Formación

• MD, MB/BS or equivalent degree with strong medical knowledge.
• Significant experience in clinical trials and pharmaceutical medicine.

Responsabilidades

• Provide medical leadership and support for clinical trials.
• Ensure medical validity and subject safety in studies.
• Act as the medical point of contact for stakeholders.

Conocimientos

Medical Leadership

Clinical Trial Protocols

Pharmacovigilance

Regulatory Guidelines

Communication Skills

Team Collaboration

Educación

MD or equivalent degree

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 :

1. 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.
2. 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. Proactively address customer concerns and correct issues in consultation with the Global Medical Indication Lead.
3. During initial review of protocols, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Acquire commitment from other functions to close gaps and address issues timely and effectively. Serve as the chief liaison between the sponsor and all PPD, part of Thermo Fisher Scientific internal departments performing the required tasks during all study phases. Educate Investigator sites by delivering protocol-specific lab procedures presentations and demonstrations during investigator meetings. Manage day-to-day activities during the clinical trial to resolve issues and answer queries.
4. Act as the medical point of contact for all internal and external stakeholders: interact with investigators as needed, answer questions from IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; provide medical training to site staff at Investigator meetings; train CRAs in new indications.
5. Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP.
6. Collaborate closely with cross-functional study team members to ensure medical risks, issues, and results are clear to all involved parties.

Education :

• MD, MB / BS or equivalent degree with strong medical knowledge, demonstrated clinical experience managing Neurology patients in hospital practice.

Knowledge, Skills, Abilities :

• Significant experience within the pharmaceutical industry, clinical trials, and pharmaceutical medicine is critically important.
• Fluent in spoken and written English.
• Understanding and experience with NDA submission process.
• Knowledge of regulatory guidelines for adverse event reporting.
• Strong communication and presentation skills; a team player.

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.