Job Details

• Management of al clinical team in accordance with the annual plan (resources / activities / timelines) and the objectives of the SDC and Sandoz. Management/overview of department costs to meet financial goals of the SDC (Swiss Development Corporation); budget planning and follow-up to ensure timely and correct financial reporting.
• Ensure that the team set up is properly and effectively aligned with the needs and goals of the SDC, effectively preserved, maintained and developed. Plan and align resources, strategies, activities and processes within the department in order to handle the given workload
• Expert input to different study types (e.g. PK, PD and Clinical endpoint studies) for respiratory and differentiated products. Contributes experience of generic inhaler development and device technology to cross-functional projects teams.
• Responsible for setting and driving the clinical development strategy for respiratory drug products in close collaboration with the development and project teams. Responsible for review and update of the clinical development strategy as needed.
• Seeking innovative solutions to support novel pharmaceutical products in accordance with project strategies
• 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
• Proactive assurance of a development and research level compliant with the current and anticipated industry trends and statutory regulations. Responsibility for the implementation of GxP standards and ensure these standards are trained upon, known and understood, and implementation is controlled. Ensures GCP audit readiness.
• Contribute as member of the clinical development leadership team to the continuous harmonization, process improvement initiatives, knowledge sharing and setting the excellence framework for clinical research, as well as contributing to implementing the vision and strategy for Product development small molecule clinical development

• Fluent in English (oral and written)
• Minimum 8 years’ experience in clinical development of respiratory generic drug products
• Able to lead a team. Knowledge of pharmacy, pharmacokinetics, pharmacodynamics, bioanalysis, statistics and/or clinical trials
• Solid knowledge of GCP and worldwide regulatory requirements related to assigned areas. Experience working with CROs. 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. Flexible to travel

Reference ID - GH/PHL/ JC//25052020//91000/Group Head- Clinical Development- Respiratory & Complex Molecules