メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

■Job Description Summary
Supporting Clinical Scientist for global studies.
May serve as Study Leader and/or Clinical Scientist for low complexity global studies or local studies.

■Job Description
MAJOR ACCOUNTABILITIES & RESPONSIBILITIES
- Support the clinical protocol development process in collaboration with line functions of the clinical trial team; 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.

- Support development of and implements study-level operational execution plan in partnership with key cross functional partners, if applicable.

- In collaboration with key cross functional partners, supports identification and selection of strategic and high performing sites to ensure recruitment commitments are met.

- Support a global cross functional CTT to ensure all trial deliverables are met; promotes realistic planning and timelines and presents actionable alternatives to accelerate timelines.

- Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations.

- 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 reporting clinical study results in CSR.

- 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.

- Support risk mitigation discussions, risk management and implementation at the trial level.

- Collaborate with key partners to align on vendor strategy and timelines for assigned studies.

- Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. May serve as Subject Matter Expert.

- 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.

■休日：完全週休二日制

QUALIFICATION & KEY COMPETENCIES
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 1+ years’ experience in clinical trials/development

Key Competencies:
- Demonstrates high learning agility.
- Demonstrated ability to drive collaborations through unpredictable circumstances and higher paced changes.
- Creates 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.
- Demonstrated organizational skills and ability to manage multiple priorities.
- Demonstrated capability to interpret, discuss and represent trial level data.
- 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.

■職種未経験者：不可