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(Associate) Medical Director - Psychiatry or Neurology, EMEA, Barcelona
Client: Thermo Fisher Scientific
Location: Barcelona, Spain
Job Category: Other
EU work permit required: Yes
Job Views: 4
Posted: 06.03.2025
Expiry Date: 20.04.2025
Job Description:
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:
This position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. This person is responsible for the design, development, and execution of Clinical Development Plans (CDPs), clinical trials, and protocols in accordance with applicable GCP regulations. This person leads and contributes 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.
This person may act as a clinical/medical representative in meetings with external stakeholders (collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (vendors, consultants, etc.), and other external audiences as needed.
We have client-dedicated and internal PPD positions currently open in the field of Psychiatry / Neurology.
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, ensuring 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 (INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
* Collaborate with leading academic medical centers
* Recruit, guide, and motivate clinical investigators
* Ensure study compliance by understanding and applying all relevant SOPs and GCPs
* Participate in long-range strategic planning
Education:
* MD degree with specialization in Psychiatry/Neurology is mandatory
* Drug Development experience in the area of Psychiatry/Neurology
* Desirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine.
Knowledge, Skills, Abilities:
* Demonstration and commitment to vigilant proactive problem solving
* Excellent leadership abilities
* Able to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols.
* Demonstrated expertise in clinical trial design, conduct, and interpretation of clinical data.
* Previous experience with regulatory submissions.
* Excellent written and verbal communication skills.
* Ability to travel.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.
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