Die beste Verbindung zwischen Unternehmen + Bewerbern
Our client is a global, publicly listed biotechnology company with more than 3,500 employees at 13 sites. The headquarter ist located in Hamburg. The key competence is the research on innovative approaches to drug discovery and development for and with leading pharmaceutical and biotechnology companies and academic institutions. By assembling top-class scientists, state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuroscience, diabetes and complications of diabetes, pain and inflammation, oncology and infectious diseases, our client has established a unique leading position.
One of the key aspect of any drug discovery and development project is biomarker research: having one or more translatable biomarkers, ranging from safety to efficacy markers as well as the ability to stratify patients, will significantly increase the chances of success during drug development and clinical trials. For this purpose, access to patient material is key.
The headqurter in Hamburg, Germany is seeking a highly motived and creative individual with understanding of translational research to lead and direct our Human Sample Initiative and Storage across the various sites. As such, we are searching for
Head of Global Human Sample Management (f/m/d)
- Facilitate development of Bio-samples business strategy, recommend and implement actions to achieve short and long term goals
- Plan, organize and oversee human sample and sample meta-data management including the collection and shipping of bio samples, sample processing and storage, and inventory management – includes ensuring that the organizations internal sample tracking databases and monitoring, tracking and reconciliation of external clinical metadata is managed to meet study and project timelines as well as ensuring adherence to GDPR/HIPAA. Ensure adherence to the organizations compliance rules for human sample management
- Coordinate with global cross-functional R&D teams to operationalize human sample management for the various projects
- Together with the Translational Biomarker team and the human sample managers, define a strategy to identify and utilize key vendors, biobanks, or clinical sites to support building disease specific and client-directed sample collections (Biobank); Support contract management and other legal requirements for this effort
- In coordination with the Translational Biomarkers department, provide education and training for sample collection, handling, and shipment, which may include optimization of laboratory manuals, SOPs, and presenting sample collection requirements at meetings. Set-up a Code of Conduct for human sample management
- Support sample analysis data transfer, data reconciliation, and data review
- Together with the Translational Biomarker Groups, provide accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, sampling materials, logistics & shipping as needed
- Provide guidance during protocol and Informed consent form development to ensure logistical feasibility of biological sampling and alignment with ICH/GCP, appropriate policies, procedures, and sample testing plans
- Support and provide guidance to human sample managers on 2-3 locations across the organizations for their day-to-day tasks in handling and shipment of human samples
- Work closely with the sample operational manager, the sample management department as well as the human sample managers to implement the database and continuously improve human sample management tracking
- A permanent position within a vigorous and exciting professional environment promoted by an open culture and a spirit of community
- Flexible working hours
- Holiday pay and annual bonus depending on performance
- Capital forming benefits
- A diverse, international workforce with a dynamic working environment that fosters creativity, innovations and teamwork
Your ideal qualifications:
- Ph.D. in Life Sciences or a related discipline
- Several years of PostDoc experience in bio sample coordination/management in a pharmaceutical / biotechnology company and/or CRO, or equivalent experience in a clinical/diagnostic laboratory
- Strong working knowledge of HIPAA or GDPR regulations and guidelines, and best practices for sample management and regulatory aspects.
- Ability to manage vendors and oversee bio sample management activities across multiple studies, indications, and/or projects
- Proven track-record in optimization of laboratory manuals, SOPs, defining and drafting training materials for human sample management and handling, and presenting sample collection requirements at internal meetings to key stake-holders
- Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment
- Excellent written and interpersonal communication skills necessary to interface with team members, project leads, legal, contract management, and external parties/clients
- Well-developed project management, project execution, communication, and presentation skills
- Effective team player, comfortable with working in a matrix role across global line functions
- The position requires fluent command of the English language. Knowledge of German is a plus, but not required
Seize this attractive opportunity now and apply online or by email.
If you have any questions, Mr. Wilke Schütte will be happy to assist you. You can reach us under +49 (0) 40 767 55 450 or firstname.lastname@example.org.
We are looking forward to receiving you application!
Elbhunter Personalberatung GmbH, Ferdinandstrasse 29 - 33, 20095 Hamburg, www.elbhunter.com