Clinical Sciences Trial Leader

Summary

Study Leader of cross-functional, clinical trial team for assigned low complexity, global clinical trials in early clinical development. Accountable for all aspects of the scientific, clinical and operational planning and implementation, from study design to data analysis and reporting of studies and assigned program-level activities according to timelines, budget and quality standards.

About the Role

Major Accountabilities:

1.
Lead or support the clinical protocol development process in collaboration with the Medical Lead and other line functions; responsible author for clinical protocols, amendments, etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which resides in other line functions; contribute to the development of clinical sections of study-level regulatory documents.

2.
Support development of strategic and scientific input into study concept, feasibility, and ability to execute; develops and implements study-level operational execution plan in partnership with key cross functional partners, if applicable.
3.
Collaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met.
4.
Lead or support a global cross functional CTT to ensure all trial deliverables are met; sets stretch goals, promotes realistic planning and timelines, and presents actionable alternatives to accelerate timelines.
5.
Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations.
6.
Lead or support the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions, and partners on data analysis and data interpretation, including safety trend analysis, signal detection, development of first interpretable results, reporting clinical study results in CSR, and
internal/external publications.
7.
Prepare, lead or support dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, to provide consolidated information for dose escalation meetings and Phase II data reviews with relevant stakeholders.
8.
Proactively lead or support risk mitigation discussions, risk management and implementation at the trial level.
9.
Responsible and accountable for forecasting and managing overall study budget(s) in collaboration with key partners.
10.
Collaborate with key partners to set vendor strategy and timelines for assigned studies.
11.
Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. Represent group on initiatives; may serve as Subject Matter Expert.
12.
Contribute to talent and career development of staff. In collaboration with the relevant manager, contributes to hiring/interview/onboarding and mentoring process for new hires.
For associates based in China and Japan, develop local early development strategy, lead local study activities throughout the study lifecycle, may serve as a regional BR liaison for scientific research activities, if required.

Education / Background:

• Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/PharmD/ Masters).

Years of Experience:
• Approximately 2+ years' experience in clinical trials/development

Languages:

Fluent English (oral and written). For Japan, Fluent Japanese (oral and written)

Key Competencies:

• Demonstrates high learning agility.
• Demonstrated ability to drive collaborations through unpredictable circumstances and higher paced changes.
• Demonstrates leadership and influence by creating a positive work environment by inspiring and encouraging mutual respect.
• Demonstrates strong interpersonal skills to build positive relationships.
• Demonstrates tolerance for ambiguity, willingness to adapt, and willingness to speak-up and challenge.
• Embraces a culture of diversity, inclusion, quality and always driving forward with integrity.
• Proficient in clinical trial methodology with an emphasis in early clinical development. Operational project management experience including excellent planning, prioritization, problem solving and organizational skills.
• Track record of successfully managing multiple clinical trials concurrently. Used to managing multiple priorities.
• Working knowledge of clinical finance principles to manage efficient expenditure to minimize variance between actual and forecasted spend.
• Maintain good knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies.

Why consider Novartis?

817million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。

約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。

ノバルティスファーマ株式会社は、スイス• バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp

Japan

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.

ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束します。

健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は [email protected]宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。

ノバルティス ファーマ「研究と開発」～科学の力で社会に貢献したいという情熱～

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

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Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Biomedical Research

Business Unit
Pharma Research

Location
Japan

Site
Head Office (Japan) (Pharmaceuticals)

Company / Legal Entity
JP05 (FCRS = JP005) Novartis Pharma K.K.

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No