Sandoz aspires to become the leading and most valued generics company.
At Sandoz, we are planningcapital expenditures of several hundred millionUSDover the next 5yearsto expand production capacity in key markets for small molecules and biopharma.
Your responsibilities include, but are not limited to:
• 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.
• Good cross-functional understanding and experience of generic inhaler development and device technology. Have a strong network to external KOLs and consultants in the respiratory area. Sound understanding of the challenges of the product development and having fair knowledge of in-vitro tests and in-vitro and in-vivo correlation.
• Experience with different study types (e.g. PK studies, therapeutic endpoint studies, scintigraphy studies). Act as the project leader of the clinical trial (internal and external team) and execute trial in accordance with project strategy.
• Contribute clinical research and operational expertise in the development of clinical trial design. Providing input to clinical development plans regarding timelines and study feasibility. Responsible for the efficient and compliant execution of clinical trials (trial timelines, budget, resources, safety, eligibility, enrollment, data consistency)
• Responsible for the preparation and/or review of clinical program documents like the Clinical Study Protocol, Report, Investigator Brochure, Annual Report, Briefing Books, and, if applicable, publication. Assure the quality of trial performance and trial documentation by implementing standardized working procedures according to SOPs, GCP and regulatory requirements and by verifying the continual compliance of each trial team member with these procedures. Resolve deviations to procedures by remedial action and training.
• Perform monitoring / co-monitoring visits according to SOPs. Prepare clinical trial medication forecast. Planning and tracking of trial budget in line with company financial reporting. Proactive knowledge sharing within department, SDC and Sandoz.
• Contribute to preparation of relevant parts of registration documents and interactions with health authorities in context of clinical studies (e.g. scientific advices, deficiencies letters). Active participation in project teams, and contributions to formulation development
• Contribute to global clinical development activities (e.g. process harmonization, knowledge sharing, participation in working groups). Contribute as agreed with line manager to other clinical related tasks like clinical due diligence. Contribute as agreed with line manager to the training and development of other clinical development team members
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• 8-10 years of experience in clinical development of respiratory drug products
• Knowledge of pharmacy, pharmacokinetics, pharmacodynamics, bioanalysis, statistics and/or clinical trials. Experience in developing Clinical development Plans
• 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
• Flexible to travel
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network