摘要
About the Role
Major accountabilities:
- Provides scientific and medical expertise on assigned clinical projects
- Contributes to clinical strategy for the Asian region
- Accountable for all aspects related to wind down projects including review of clinical data, and oversight of all CSR related activities
- Contributes to clinical trial data medical/scientific review for assigned TCO projects and coordinates data analysis and interpretation including the development of first interpretable results, clinical study report, publications, and internal/external presentations.
- Builds and maintains high performance cross functional teams in TCO and with partners
- Manages stakeholder engagements internally and externally
- Mentors and coaches junior TCO team members
- Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Leads or assists with relevant trainings across TCO India
- Advocate continuous improvement of quality
- Ensure all activities of associates comply with company standards and local regulations
Key performance indicators:
- Management of assigned studies to ensure execution according to timelines, budget and with high quality, ensuring adherence to international and local regulations.
- Demonstrates excellent scientific writing skills to enable the development of quality trial reporting, and regulatory documents.
- Effective risk management in design of synopses, operational planning, and clinical execution.
- Contribution towards objectives set for the department.
- Feedback from external and internal customers.
- Adherence to Novartis Values and Behaviors.
Minimum Requirements:
MD required. Board certification or prior industry experience in oncology required.
Experience from early clinical development preferred
Work Experience:
- >5 years of pharmaceutical/biotech industry experience
- Experience with oncology trials
- Experience with early development trials
- Knowledge of Good Clinical Practice (GCP).
- Strong operational project and management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
- Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects.
- Strategic thinking: ability to network with and influence opinion leaders, clear and logical presentation of complex strategic issues.
- Clear written and verbal expression of ideas, an active/proactive communicator.
- Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships.
- Used to working independently and in a team, being flexible and adapting in a changing environment.
Languages :
- Fluent oral and written 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? http://www.novartis.com/about/strategy/people-and-culture
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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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
