Clinical Development Lead Oncology (m / f / d) – IVD / Liver Indication / Medical Device / ICH-GCP, IVDD / IVDR, MDR, FDA, NMPA / VACC / English
Project: For our customer Roche Diagnostics International AG based in Rotkreuz, we are looking for a highly qualified Clinical Development Lead Oncology (m / f / d).
Background: The Clinical Development Lead Oncology is responsible for planning and implementing clinical development activities for novel medical diagnostic solutions in the area of Chronic Liver Diseases at Roche Diagnostic Solutions (RDS), with a primary focus on Liver fibrosis. The role involves contributing to Roche Diagnostics' long-term medical value strategy and pipeline development.
The perfect candidate: The Clinical Development Lead manages clinical development activities for assigned oncology products. Requires a good understanding of clinical study design, scientific writing, and experience leading matrixed teams. A detailed understanding of the healthcare industry or equivalent academic experience is essential.
Tasks & Responsibilities:
1. Serve as a subject matter expert for Liver Oncology, including clinical study design and evidence strategies for internal and external stakeholders.
2. Review study results critically and generate protocols and reports to support new product development.
3. Collaborate with colleagues from Business, Medical Affairs, Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, and other functions to ensure effective clinical development strategies.
4. Build and maintain strong, collaborative relationships with cross-functional leaders, stakeholders, and partners to meet business goals and ensure operational excellence.
5. Represent Clinical Development, establishing effective relationships for new and existing products, including clinical utility and claim extensions.
6. Lead medical/scientific input and regulatory documentation preparation, including submissions and reviewer responses.
7. Drive innovation, competitive differentiation, early pipeline activities, and develop IP strategies.
8. Conduct comprehensive literature reviews, collate scientific information, and create new scientific content independently.
9. Demonstrate leadership skills; mentor team members and foster professional growth.
Must Haves:
* Medical degree or advanced degree in Life Sciences (PhD, PharmD, or equivalent).
* At least 2-3 years of industry experience post-PhD or 5+ years in IVD.
* Strong experience in liver indications (Fibrosis and/or Liver cancer).
* Experience in all stages of global IVD or Medical Device development, including protocol design, report writing, and leading matrixed teams.
* Knowledge of applicable standards and regulations (ICH-GCP, IVDD / IVDR, MDR, FDA, NMPA), especially in US global studies and FDA negotiations.
* Understanding of agile methodologies and VACC principles; ability to foster a collaborative environment.
* Excellent communication, presentation, and negotiation skills in English.
* Flexibility and adaptability in a fast-paced, matrixed environment.
* Strong analytical skills and strategic mindset; ability to work independently.
Additional Details: Reference Nr.: 924323TW; Role: Clinical Development Lead Oncology (m / f / d); Industry: Pharma; Workplace: Rotkreuz (Hybrid); Full-time; Start: ASAP; Duration: until 31.08.2026; Travel: max. 10-15%; Deadline: 29/07/2025.
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