Active participation in development of formulations. Setting clinical strategy (HV or patient studies). Independently plan, manage, and oversee clinical studies in accordance with project strategy, resources, timelines, and regulatory and professional standards.
Lead operation related activities in close collaboration with Group heads.
Selection and management of activities performed by contract organizations; cost optimization; professional and regulatory compliance; efficient coordination and management of costs for activities performed by contract organizations. Responsibility for GxP standard implementation and ensuring that these standards are trained on, known, and understood, and that implementation is controlled.
Ensures GCP audit readiness.
Contribute as a member of the clinical development team to continuous harmonization, process improvement initiatives, knowledge sharing, and setting of the excellence framework for clinical research, as well as contributing to implementing the vision and strategy for Product development small molecule clinical development.
Other tasks determined during the annual objectives setting process and by KPIs.
Other tasks as assigned by the supervisor, and tasks based on a specific appointment,
Responsibility for continuous personal and professional development (knowledge, skills, behaviors).
Qualifications
Timely submission and delivery of high quality clinical trial documentation.
Responsibility for the budget of the respective clinical trials.
May be located at any of the locations for the Sandoz Development Centres. Other locations by agreement with management.
Minimum 8 years of experience in clinical development or associated fields.
Knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or clinical trials.
Solid knowledge of GCP and worldwide regulatory requirements related to assigned area.
Solid medical/scientific writing skills.
Computer literacy.
Ability to analyze, discuss, interpret and present scientific data.
Strong communication and organizational skills.
Proven people management skills with demonstrated expertise in working on teams.
