Location: Stockholm, Gothenburg, Malmö
Assignment: 12 months with possibility to transfer into employment
• Leads the cross-functional global Clinical Team and ensures delivery of all clinical program activities to agreed timelines, budget and quality.
• Coordinates, contributes to and ensure delivery of key documents such as clinical development plans, study design synopses and clinical parts of regulatory documents, and reviews clinical study documents such as study protocols, protocol amendments, study reports and key project management plans (e.g., communication, quality and risk management plans).
• Oversees the selection and management of external service providers for clinical program activities and deliverables.
• Forecasts and manages resources, budget, timelines and risks for clinical programs and ensures that all activities and deliverables are compliant with Companies SOPs, ICH/GCP guidelines and regulatory requirements.
• Life science degree with experience of clinical drug development.
• Extensive experience of global strategic clinical development from all phases (phase 1 to 3, IV and LCM).
• Demonstrated ability to lead multi-disciplinary teams including team building, negotiation and conflict resolution.
• Experience of budget and resource forecast and management.
• Experience with the development of global clinical development plans.
• Experience from leading through global clinical outsourcing and working with external service providers.
• Experience of NDA/BLA and/or MAA, and clinical product support activities desired.
• A high level of proactivity, commitment, and energy.
• Strong leadership and coaching skills.
• Strong interpersonal skills with communicative and flexible attitude.
• Excellent problem-solving skills and a “can do attitude”.
• Strong individual initiative, organization skills and multi-tasking abilities.
• Strong customer-oriented mindset.
• Excellent written and oral communication skills in English.
For more information about the position
Please contact Morgan Eilenberg at +46 733 590 550 or at firstname.lastname@example.org
or Anders Larsson at +46 73 203 46 91 or email@example.com
All enquiries will be handled with confidentiality. If interested, please apply as soon as possible. Applications will be processed on an ongoing basis.