Clinical Program Leader
TFS, Sweden
Job Description
TFS offers the opportunity to work at our clients' office who is an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients, and providing treatment and services to them.
Clinical Program Leader
The company now aims to strengthen the organization with a Clinical Program Leader (CPL) to join their Clinical Program Management (CPM) department. The position will report to the Lead Clinical Program Leader in Stockholm.
Clinical Program Management is a part of Research amp; Development, and has the overall responsibility to secure planning, execution and reporting of clinical programs and individual studies in line with the project/product strategy and regulatory requirements. We support all phases of drug development with operational focus on clinical studies in phase 1 to 3.
Key Responsibilities:
- Leads and manages 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 SOPs, ICH/GCP guidelines and regulatory requirements.
Requirements
Qualifications:
- Life science degree with a minimum of 10 years’ experience of clinical drug development.
- Extensive experience of global strategic clinical development from all phases (phase 1 to 3, 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.
Personal attributes: