Clinical Development Lead

hace 1 semana


Barcelona, Barcelona, España Mygwork A tiempo completo
Lead Clinical Development

This position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.

Key responsibilities include the design, development, and execution of Clinical Development Plans (CDPs), clinical trials, and protocols in accordance with applicable GCP regulations.

As a key member of the clinical research team, you will lead and contribute 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.

You will also act as a clinical/medical representative in meetings with external stakeholders, partners, and other external audiences as needed.

In this role, you will have the opportunity to contribute to the development of life-changing therapies and make a positive impact on a global scale.

At Thermo Fisher Scientific, you will discover meaningful work that enables 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.

A Day in the Life:

* Provides medical content and leadership of the clinical studies

* Medical Monitoring of clinical studies

* Establish and approve scientific methods underlying the design and implementation of clinical protocols

* Ensure study subject safety

* Regularly review adverse event, laboratory, and other clinical data, ensure reporting is done on a timely basis

* Collaborate with the study executive and independent safety committee when needed

* Represent clinical research through membership on trial teams

* 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.)

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