Clinical Outsourcing Director - To Oncopeptides
We are looking for a Clinical Outsourcing Director within the Clinical Operations department at Oncopeptides. Oncopeptides is a global biotech company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The Company has recently been granted accelerated approval by the U.S. The company, which is listed on the Stockholm Stock Exchange, was founded in Sweden year 2000 and operates globally.
The Clinical Outsourcing Director (COSD) main role is to be responsible for developing outsourcing strategies and leading the outsourcing process for clinical studies within the Clinical Operations (CO) department in collaboration with the study team.
The COSD will also be responsible for the development and improvement of outsourcing processes within Clinical Operations as well as acting as subject matter expert for outsourcing strategies and recommendations.
The clinical development program at Oncopeptides is focused on melflufen and patients with difficult to treat hematological disorders and in addition the first clinical study with a second drug candidate will start in the near future. More information on the clinical studies can be found on www.oncopeptides.com.
- The Clinical Outsourcing Director (COSD) main role is to be responsible for developing outsourcing strategies and leading the outsourcing process for clinical studies within the Clinical Operations department at Oncopeptides in collaboration with the study teams.
- The COSD will drive the alignment of outsourcing strategies, perform outsourcing market surveillance and act as subject matter expert for clinical outsourcing strategies and recommendations.
- The COSD is responsible for the development and maintenance of outsourcing and contract processes, templates and tools (SOPs, Wis etc.) in collaboration with the Process Lead.
- The COSD work in close collaboration with the Global Project Leads (G-CPLs) and supports the Clinical Operations Directors (CODs) with focus on the out-sourcing and contract process.
- Responsible for planning of the administrative support provided to the COSD function by the Contract Administrator.
- Life Science university degree (e.g. MSc, BSc, RN).
- Strong track record of leading the outsourcing process of clinical studies at the Sponsor, from request for proposal (RFP), negotiations, contract finalization, maintenance phase (issues escalation) and up to contract closure. Previous experience of developing contract and CDA templates is beneficial.
- Experience from setting up out-sourcing and contract processes, working instructions, templates and SOPs is beneficial.
- Clinical operations experience in Pharma industry or CRO and understanding of GCP and other relevant laws and regulations.
- Proven track record of Project Management, team leadership and working independently.
- Excellent written and verbal skills in English.
Welcome to apply through: www.haegercarlsson.com
Questions are answered by Gunilla Haeger +46 (0)70 – 461 93 87, firstname.lastname@example.org or
Anna Wikman +46(0)73-539 33 87, email@example.com