Clinical Development Lead Oncology

**Project**:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly Clinical

Development Lead Oncology (M/F/d).

**Background**:
The Clinical Development Lead Oncology is responsible for planning and implementation of Clinical

Development activities for novel medical value diagnostic solutions in the areas of Chronic Liver Diseases at

Roche Diagnostic Solutions (RDS), with a primary focus on Liver fibrosis. The Clinical Development Lead will

contribute to the development and implementation of Roche Diagnostics

long-term, medical value strategy and pipeline..

The Clinical Development Lead is responsible for planning and implementation of Clinical Development

activities for assigned Oncology products. Good understanding of clinical development including clinical study

design and scientific writing experience as well as leading matrixed teams. Detailed understanding of the

healthcare industry or equivalent academic experience.

**Tasks & Responsibilities**:
for internal and external stakeholders in the assigned indication area.
- Responsible for critical review of study results, protocol and report generation to support new product

development.
- Works with colleagues from Business, Medical Affairs, Clinical Operations, Regulatory Affairs, Biometrics,

Development, Quality, and other functions to ensure appropriate implementation of clinical development

strategies.
- Builds and maintains strong, collaborative relationships with cross-functional leaders, key internal and

external stakeholders and other alliance partners, in meeting business goals and ensuring operational

excellence.
- Act as an ambassador and representative of Clinical Development establishing effective collaborative

relationships with key functions for new and existing products, incl. clinical utility, intended use and claim

extensions.
- Play a leadership role in maintaining clinical, regulatory, and scientific expertise as it relates to IVD product

development and regulatory documentation. Leads medical/scientific input and preparation of regulatory

submissions as well as responses to reviewers from regulatory agencies.
- Drives competitive differentiation, innovation and early pipeline activities and develops intellectual property

strategy.
- Responsible for comprehensive literature reviews, supervises collation of relevant clinical and scientific

information from different sources, and creates new scientific content (without guidance/direction).
- Demonstrate leadership skills; ability to mentor and provide an environment for personal and professional

growth.

**Must Haves**:

- Medical degree or advanced degree in Life Sciences (PhD, PharmD or equivalent degree) with relevant

expertise in the Healthcare Industry and/or academic institutions
- Min. 2-3 years of industry experience after PhD or coming straight from the industry with at least 5+ years of

experience in IVD
- Strong experience in liver Indication (Fibrosis and/or Liver cancer)
- Min. 5+ years academic, diagnostics or pharma industry experience, preferably, having experience in IVD or

Medical Device development in all stages of global studies, development of study protocol design, report

writing and leading matrixed teams
- Ability to lead clinical development studies/programs and good knowledge in applicable standards and

regulations (ICH-GCP, IVDD/IVDR, MDR, FDA, NMPA regulations etc.) especially in global studies in the US and

negotiation with the FDA
- Understands agile culture and exhibits an agile mindset. Embraces the VACC (Visionary, Architect, Coach,

Catalyst) principles, fosters excellence and enables a productive and collaborative work environment
- Excellent verbal and written communication, presentation and negotiation skills in English
- Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross team collaboration is crucial.
- Excellent analytical skills and strategic mindset. Ability to work independently

**Reference Nr.: 923977SDA**

**Role: Clinical Development Lead Oncology (M/F/d)**

**Industrie: Pharma**

**Workplace: Rotkreuz (Hybrid working model)**

**Pensum: 100%**

**Start:ASAP**

**Duration: 12++**

**Travel: max. 10 - 15%**

**Deadline04/02/2025**

**Job Type**: 100%

Work Location: On the road