Sergiu Dalm, PhD

Experience

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  Medical Pharmacology (LUMC)

  Jan 1997 - Jan 2002

  Laboratory assistant

  Project: ‘Stress effects on cognitive performance of Apolipoprotein-E knockout mice’; pre-clinical research on the interaction between the genetic background and environmental stress factors on cognitive performance. Co-authored 5 articles in peer reviewed journals. Presented specific results during national congresses. Coached several trainees during their internship. Gave several seminars on topics related to animal cognition and behavioral testing.

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  Leiden University

  Sept 2002 - Sept 2007

  PhD

  Title of dissertation: ” Towards a mouse model of depression: a psychoneuroendocrine approach.”PhD obtained on 21November 2012Summary: In present day society, repeated exposure to uncontrollable stress (e.g., loss, workload, no work) is experienced more often. One of the consequences is that more people are suffering from depression. Current behavioral and drug therapy is effective for a subset of patients only; new drugs are needed. sThe key symptom expressed is anhedonia: the reduced responsiveness to positive stimuli. I developed a mouse model (mice exposed to rats) that mimics the expression of anhedonia. Read-out parameters included: emotional-, exploratory,-neuroendocrine responses, learning and memory paradigms. Stress favored the use of the less flexible, rigid stimulus-response learning strategy (in mice and humans). In addition, behavioral inhibition was accompanied by alterations in stress related receptors. Interestingly, positive stimuli and application of drugs targeting the stress system relieved some of the induced symptoms. Concluding, the model shows similarities with symptoms seen with depression and can partially be restored by exposure to positive stimuli and drugs that target the stress system.Please see link to my dissertation on line: http://hdl.handle.net/1887/20152 Show less

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  Centocor BV Leiden

  Jan 2008 - Dec 2008

  Trial Document Service assistent/head

  Performing quality checks of essential documents (including: Informed Consents, FDA1572, CV’s, regulatory documents etc.) obtained by CRO representatives from sites, to initiate sites at study start-up. Continuous review of document updates during trial execution. Communicated with study team and CRO aligned team. In case of discrepancies, to ensure correct follow up and issue resolution. Involved in quality review of informed consents for different therapeutic areas. Participated in requesting and processing new and revised trial insurances. This involved collaborating with the broker representative, especially during the annual renewals of the trial certificates. During the last 4 months of 2008, mainly responsible for the process of dissolving the TDS department. Show less

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  Quintiles

  Nov 2008 - Aug 2010

  Quality Compliance Specialist - outsourced to JnJ Centocor BV Leiden

  General support for JnJ's Quality Compliance Specialists/Manager, such as review of monitoring visit reports, follow up letters, maintaining database to track all activities of the Quality & Compliance group.

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  Johnson&Johnson - Quality Management Center of Excellence

  Sept 2010 - Dec 2021

  Quality Monitoring & Compliance Associate - Neuroscience/Oncology

  Within the department of Quality Management & Compliance accountable for the setup / execution of trial specific quality compliance plans for which trial coordination and site management is conducted by a Clinical Research Organization (CRO) and JnJ pharma R&D companies. Ensuring regulatory requirements, SOPs and trial specific agreements are met. Involved in monitoring the quality for trials in the following therapeutic areas: Neuroscience, Immunology, Internal Medicine and Oncology. Contributed in the creation of quality compliance plans. Continuous review of CRO-specific monitoring visit reports. Meetings with study teams from the sponsor and the CRO’s to discuss corrective and preventive actions that need to be initiated in case of non-compliance. Review of audit reports and involved in the CAPA response to the audit findings. Facilitated Onsite Quality Monitoring visits to sites which have reported possible non-compliance issues. Providing training sessions to the local sponsor representatives, who are conducting these visits. Subsequent visit reports review and follow up on reported issues with the CRO’s. Providing Good Clinical Practices (GCP) guidance to workgroups and to business partners. Show less

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  Johnson & Johnson

  May 2014 - now

  Manager Quality Planning & Strategy overseeing the daratumumab (DARZALEX) compound. Indications include: multiple myeloma, Systemic Amyloid Light-chain (AL) Amyloidosis. Responsible for quality oversight to facilitate timely risk identification and issue management, and high quality submissions in close collaboration with internal- and external business partners. In addition to providing quality support to trials teams within the Therapeutic Area of Oncology:-Quality Leader within TrackWise CAPA mngt system 2017-2019-CREDO (co-)Lead of the Quality Planning & Strategy department 2018-2020

  • Manager Risk Management Quality Planning & Strategy - Oncology

    Sept 2021 - now

  • Quality Monitoring & Compliance Sr. Specialist,

    May 2014 - Aug 2021