Clinical Development Leader

vor 3 Wochen

Rotkreuz, Schweiz Work Selection Vollzeit

**Beschreibung**:
For our international partner, Roche Diagnostics International Ltd. based in Rotkreuz, we are looking for a qualified and motivated **Clinical Development Leader** for one year with option for extension.

In this role you will provide clinical expertise in heart failure care for the medical value innovation pipeline of novel diagnostic solutions and disease management solutions. In close collaboration with various expert stakeholders, you will define together the clinical product specifications, development strategies, and clinical evidence options for product exploration, development, registration and adoption. The incumbent will seek to inspire and ignite passion in others to create sustainable change, and to leverage the efforts of a diverse range of people and teams.

**Tasks**:

- Provide clinical expertise and leadership for the HF clinical development programs
- Design clinical studies towards product development and registration
- Drive medical value innovation and clinical differentiation of key products
- Drive exploratory research and validation towards novel product opportunities including digital clinical decision support and disease management solutions
- Drive Intellectual Property generation
- Support the disease area network in the implementation of the overall cardiac clinical strategy
- Medical risk and safety assessments

**Must Haves**:

- M.D. with experience in heart failure (HF)
- 5+ years of working experience
- Experience in clinical evidence generation, study design, patient pathways and disease management
- Previous experience of working in an international business climate and matrix environment
- Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
- Experience in agile project management environment
- Understanding of Biostatistics and Epidemiology
- Cardiac biomarker experience and digital product development experience are strong assets
- Highly motivated individual with a positive mindset with strong team-working skills
- Visionary and strategic mindset for clinical development of new products and product offerings
- Ability and willingness to travel approximately 20% of time
- Knowledge and understanding of different diagnostic technologies and methods are advantageous
- Excellent English skills, both written and spoken

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