Clinical Development Lead Oncology (m/f/d)

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 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 perfect candidate:
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:
Serve as a subject matter expert for Liver Oncology, clinical study design and evidence generation strategies 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%
Deadline: 04/02/2025

If you are interested in this position, please send us your complete dossier via the link in this advertisement.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.