Trial Supply Manager
We are looking to recruit a trial supply manager to our clinical operations group. The location is at our newly established premises in Solna.
As trial supply manager you will have an important role in the in clinical operations, operating on a global scale. You will be directed by the objectives and demands of the development projects.
The role in general
The area of responsibility is broad, including all concerned activities from prospective planning, forecasting to overseeing/steering set-up, conduct and closure of clinical trial supply (including labeling, packaging, storage and distribution) of Investigational and Non-Investigational Drugs (including comparators and rescue medication) and auxillary materials. Furthermore, the right candidate will set-up and supervise the undisrupted supply chain (including temperature controls, as and when applicable) and organize retrieval from/destruction at investigational sites and respective documentation (overall drug accountability) in close cooperation with the concerned Service Providers (CROs and CMOs).
As clinical supply manager in the clinical operations group your main responsibilities include:
- Plan and coordinate Investigational Medicinal Product and Non-Investigational Medicinal Product (N)IMP, production and delivery in collaboration with the CMC project managers, and take the lead in labeling and packaging design
- Actively contribute as Subject Matter Expert (SME) to the outsourcing process for labeling/packaging and distribution/retrieval/destruction of (N)IMP and other clinical trial (auxillary) material according to all applicable national and international guidelines and other requirements
- Act as an integral part of the project teams on a program level, directed by the objectives and demands of the projects, including planning, hands-on work, and follow-up of activities to execute on project/company goals within budgets and timelines
- Hold responsibility of the overall drug accountability on project level
- Act as an integral part of the trial teams and be responsible and accountable for planning, directing, monitoring and coordinating all activities in context of (N)IMP and auxillary materials on trial level
- Interact with / oversee concerned activities with main CROs during trial set-up, conduct and closure, including, but not limited to, set-up of Interactive Response Technology (IRT) and adequate documentation of drug supply related procedures
- Develop and implement Investigational Medicinal Product Manual (IMP Manual), including but not limited to, drug handling, storage, administration, retrieval/destruction and concerning documentation, and hold responsibility for the trial-specific overall drug accountability
- Provide continuous and transparent information and recommendations on a project/program level and to senior management functions
The right candidate fulfills the following qualifications:
- An advanced degree in Life Science or Pharmacy, such as MSc degree or higher
- At least 5 years of experience from the biotech/pharmaceutical industry in a similar role
- Experience from work with regulatory requirements for drug/material supply, import/export and labeling, packaging and distribution of clinical trial material and (N)IMPs
- Experience in forecasting
- Advanced knowledge of Excel and/or other tracking tools
- Experience from working in complex projects/programs in cross-functional teams in the biotech/biopharmaceutical industry
- Advanced English (oral and written), proficiency in the Swedish language (oral and written) is an advantage
To be successful in the role you need to have strong skills in planning, reporting, logistics, proactivity, orientation to details, communication and commitment to quality and performance. You need to have a strong sense of personal accountability, working independently as well as in teams. You are self-motivated, driven, results oriented with good problem-solving skills, and have an analytical mindset. The role requires good capabilities to coordinate and make long-term plans, monitor the plans and to handle/mitigate deviations as they occur and provide sound solutions to problems and identify with whom to communicate and interact with. You have excellent communication skills and a high sense of responsibility and diligence and enjoy working in an operational role that includes administrative tasks.
We will interview candidates from end of August 2020 and continuously, and welcome your application today!
Please send your application (CV and a note on why you think this is your next step) to email@example.com. Please note that applications will be reviewed and handled from mid-August 2020. If you have any questions about the role, please contact Head of Clinical Operations, Gerda Vlasitz, at firstname.lastname@example.org.
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Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.
Upcoming reports Financial calendar
- Interim Report January to March 2020 (May 15, 2020)
- Interim Report January to June 2020 (August 21, 2020)
- Interim Report January to September 2020 (November 13, 2020)
- Year End Report 2020 (February 2021)