345041BR
May 10, 2022
India

Job Description

Sandoz aspires to become the leading and most valued generics company.

At Sandoz, we are planning capital expenditures of several hundred million USD over the next 5 years to expand production capacity in key markets for small molecules and biopharma

Your responsibilities include, but are not limited to:

• Lead operation related activities in Respiratory in close collaboration with Group heads
• Independently plan, manage and oversee complex clinical studies in Respiratory in accordance with project strategy, resources, timelines, and regulatory and professional standards.
• Active participation in project timelines and contribution to the development of complex formulations. Experience in generic inhaler development and device technology to cross-functional project teams.
• Responsible for setting and driving the clinical development operation strategy for respiratory drug products in close collaboration with the development and project teams. responsible for the review and update of the clinical development strategy as needed.
• 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 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 the 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

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Minimum 10 years’ experience in clinical development or associated fields
• Knowledge of Respiratory, inhalers, 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 soft skills with demonstrated expertise in working on teams, Flexible to travel

WHY NOVARTIS

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
SANDOZ
Product Dev SZ
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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345041BR

Senior Clinical Development Manager

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