Clinical Development Lead Oncology (m/f/d)
Project information
- 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, with a primary focus on Liver fibrosis. The Clinical Development Lead will contribute to the development and implementation of long-term, medical value strategy and pipeline
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.
Profile
- Medical degree or advanced degree in Life Sciences (PhD, PharmD or equivalent degree) with relevant expertise in the Healthcare Industry and/or academic institutions
- Experence in industry experience after PhD or coming straight from the industry with experience in IVD
- Strong experience in liver Indication (Fibrosis and/or Liver cancer)
- 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
Benefits
- Join one of the world's leading pharmaceutical companies!
- Internal Career Opportunities
- International and Diverse Environment
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
- 1
- 2
- 3
- 4
1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
© Copyright Hays plc, . Das Wort HAYS, die H-Symbole, „Hays Working for your tomorrow" und „Powering the world of work" sowie damit verbundene Logos und Illustrationen sind eingetragene Markenzeichen der Hays PLC. Die H-Symbole sind Originaldesigns, die in vielen Ländern geschützt sind. Alle Rechte vorbehalten.