Clinical Development Medical Manager

Key Responsibilities：

• 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 responsible 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 Surveillance (PASS) protocols and PASS Reports; May take on some responsibilities of China Associate Clinical Development Medical Director (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

Commitment to Diversity and Inclusion / EEO:

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

Essential Requirements:

• 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

Desirable Requirements:

• MD required,     2-4 years’ experience in clinical practice preferred

• Excellent verbal and written communication skill in Chinese and English

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:  https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

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.

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