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Die Position
In Roche we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At CICoR, we aspire to help patients by leveraging China’s life science ecosystem to accelerate scientific innovation and develop breakthrough medicines. Together, we create a culture defined by curiosity, responsibility, and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.
The vision of CICoR ED is to lead the formulation and execution of China strategy for global early clinical development, fostering collaboration with internal and external partners. We also bring critical clinical insights to CICoR discovery projects. Our goal is to prioritize the most promising scientific discoveries and accelerate their translation from the lab to the clinic - quickly, effectively, and safely.
Roles and Responsibilities
- Represents as the China Clinical Lead in the global clinical project team, driving China strategy for global early clinical development through collaborative partnership with global and local organizations
- Ensures the clinical study design, execution, and scientific and medical data interpretation in line with GCP and highest medical and scientific standards, the most recent international and local treatment and health authority guidelines and cutting-edge disease endpoints, including novel and surrogate endpoints.
- Creates and fosters local cross-functional collaboration to steer the molecule integrated end-to-end China development plan, to lead the feasibility assessment, and to ensure timely regulatory, clinical, preclinical, late stage, commercial and external expert input into the China clinical development strategy
- Is the Key interface between the global Asset Team and the local Clinical Operations, Clinical Sites and investigators, and CROs, for study-related activities
- Serves as the DA Strategy Lead for CICoR discovery projects, providing critical clinical insights on indication prioritization, patient population selection, and competitive landscaping.
Additionally:
- Is a Key translational representative on discovery projects; shapes the hypotheses to be tested in clinical experiments.
- Works closely with the Biomarker Experimental Medicine Leader to develop biomarker strategies on discovery projects.
- Represents Roche at congresses and to local authorities.
- Maintains and expands a network of external principal investigators, clinical collaborators, and advisors in China.
- Acts as key local clinical scientific contact/medical monitor, answers selected medical queries when needed.
- Contributes to the review and interpretation of clinical data and the development of content needed for governance committee interactions seeking Go/No Go decisions.
- Participates in Due Diligences and non-project related work streams representing the function whenever applicable.
Qualification
Thrive in a dynamic, inclusive environment, which gives you full accountability for your contributions and own development. Resourceful and flexible in problem solving, and in working in a collaborative and inclusive manner. Transparent and have a sense for ensuring that everyone has the required information at all times.
- Hold an MD (MD preferred, PharmD or PhD if approved qualified) and minimum of 5 years of experience in clinical research (industry/hospital), including experience in diverse working environments; physician scientist desirable.
- Preferably, bring drug development experience in the pharmaceutical industry, including taking a compound to a Proof-of-Concept decision and general knowledge of all aspects and scientific methods used in Clinical Development, including both Early and Late stage.
- An advocate for change, encouraging adoption of new approaches, with agility and continuous improvement.
- Bring a strategic mindset and ecosystem thinking and strong analytical skills, strong communication and interpersonal skills; and the ability to influence others and drive consensus building.
- Fluent in written and verbal English
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.