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Clinical Development Medical Manager

Employer
Novartis
Location
Beijing, China
Salary
Competitive
Closing date
Apr 6, 2023

View more

Discipline
Health Sciences, Medicine
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma

Job Details

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020- 2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Location: Open to Shanghai/Beijing city

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Responsible for China clinical development strategy in one or several development programs
• Leads medical feasibility at indication level, often prior to the development of study concept, may responsibile for providing study concept sheet
• Responsible for preparing Clinical Overview (CO), Summary Of Clinical Safety (SCS), Summary Of Clinical Efficacy (SCE), China CSR Appendix, Briefing Book (BB) for pre-IND meeting, medical responses to China regulatory authority
• Ensures the accurate translation of medical documents in CTA and NDA dossier (e.g., protocol, IB, CO, SCE, SCS, China CSR Appendix, BB, responses to China regulatory authority questions)
• Plans and executes publication and clinical communication strategy in coordination with Medical Affairs (MA), and provide input into key external presentations
• Leads interactions with local external medical experts (e.g., regulatory authorities, key opinion leaders) at authority consultation, advisory boards, patient advocacy groups and investigator meetings
• Responsible for developing Post Approval Safety Survelliance (PASS) protocols and PASS Reports
• May take on some responsibilities of China Associate Clinical Development Medical Direcotor (aCDMD), under global aCDMD or China Development Unit Head
• Contributes to talent and career development of China CD associates through on-boarding, coaching, and/or mentoring support
• May act as Clinical Development Physician (CDP) in China when required
• Takes on special task assigned by the line manager

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

What you’ll bring to the role:
• 3 - 5 years relevant industry experience
• Established disease knowledge is preferred with proven ability to interpret, discuss and present efficacy and safety data
• Strategic thinking by actively seeking information and understanding the impact of the external environment and internal business priority on project/study level
• Working knowledge of Good Clinical Practice (GCP), clinical trial design, statistics, and regulatory and clinical development processes
• Have strong desire to coach less-experienced associates and/or be able to function effectively as a medical leader in a cross functional team
• Demonstrated ability to establish effective working relationship with key investigators
• Strong learning agility
• Strong interpersonal skills
• Strong negotiation and conflict resolution skills
• Proven ability to work independently in a cross functional team setting

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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!

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message

无障碍及便利设施

诺华承诺与残障人士共事并为他们提供合理的便利设施.如果您由于健康状况或残障,在招聘过程的任何环节需要合理便利设施,或者为了履行职位的基本职能,请发送电子邮件至 [email protected] ,告知您的需求和联系方式,并在邮件中附上您的职位申请编号.

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

Company

At Novartis, we are reimagining medicine.

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.

We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!

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