Director Clinical Supply Management - Affibody - Solna
We are looking for you who wants to be part of the development of new biopharmaceuticals and who wants to help drive science and product development at a successful and expanding biotech company. You will focus on forecast, plan and overseeing the supply of Investigational and Non-Investigational Drugs and auxiliary materials. it is a broad position with broad responsibility having impact on large areas of development.
The Director Clinical Supply Management will forecast, plan and oversee the supply (including labeling, 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 in close cooperation with the concerned Service Providers (CRO and CMO).
Key Responsibility Areas
- Plan and coordinate Investigational Medicinal Product and Non-Investigational Medicinal Product (N)IMP, production and delivery with CMC, 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 program level, directed by the objects and demands of the preclinical and clinical 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 CRO and CMO during trial set-up, conduct and closure including, but not limited to, set-up of Interactive Voice Recording /Response Systems (IRT and IxRS) and proper documentation of drug supply related procedures.
- Delegate tasks and receive reporting from different parts of the company and from external parties and contract organizations.
- 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 study-specific overall drug accountability.
- Provide continuous and transparent information and recommendations to the Head of Clinical Operations and Compliance and other Senior Management functions.
Desired Education, Experience and Skills
- An advanced degree in Life Science or Pharmacy such as MSc degree in life-science/engineering/pharmacist or higher.
- At least 5-10 years of experience in 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.
- Advanced English (oral and written)
- Self-driven, service minded, proactive and flexible with excellent communication and collaboration skills
- High sense of responsibility and diligence and enjoy working in an operational role that includes administrative tasks
- Strong team working skills required to work effectively and establish/maintain beneficial working relationships with internal/ external partners
- Ability to work independently as well as in cross-functional teams
- Result oriented and self-motivated
- High organizational skills and good coordinating skills
- Risk identification and management
- Proficiency in the Swedish language (oral and written) is an advantage
Application and more information
Please call Knut Natt och Dag on +46 722 16 68 00 if you have any questions. You are welcome with your application by e-mailing your CV and personal letter to firstname.lastname@example.org as soon as possible. We are working continuously with this recruitment project and would like to receive your application as soon as possible. Write "Director Clinical Supply Management Affibody" in the subject field.
Affibody is cooperating with Aktivia Science Work in this recruitment. Aktivia Science Work is a recruiting and consulting company within Life Sciences specialized in positions within the pharmaceutical industry - from early discovery pharmaceutical development and clinical development to the market place. We are members of SwedenBIO.