Clinical Development Leader
vor 1 Monat
Clinical Development Leader (m/f/d) – Neuroscience / Neurology / IVDR/FDA / Clinical study Design/ Clinical Science / Agile / English
Project:
For our customer Roche Diagnostics International AG based in Rotkreuz, we are looking for a highly qualified Clinical Development Leader (m/f/d).
Background:
Within Clinical Development, clinical expertise and leadership is provided for the medical value innovation pipeline of novel diagnostic solutions across all relevant disease areas at Roche Diagnostic Solutions (RDS). In close collaboration with many stakeholders, Clinical Development defines the clinical product specifications, development strategies, and clinical study designs for product registration with adept medical writing, regulatory, and safety expertise.
This position is within the Clinical Development NEO (Neurology, Endocrinology and OBGYN) subchapter, focusing on Neurology where the Clinical Development Leaders aim to develop diagnostic solutions to address unmet medical needs in neurology, especially in Alzheimer’s and Parkinson’s Disease as well as Multiple Sclerosis.
The perfect candidate is either a Medical Director or PhD with around 5 years of experience in Clinical Development / Clinical Science. The candidate should have sound knowledge in neurodegenerative diseases and experience in regulatory submissions (IVDR/FDA).
Tasks & Responsibilities:
- Responsible for planning and implementation of Clinical Development activities for assigned products.
- Designing scientifically sound clinical studies in cross-functional teams, including clinical study design and execution, critical review of study results, protocol, and report generation to support new product development.
- Conducting comprehensive literature reviews, collating relevant clinical and scientific information from different sources, and creating new scientific content with minimal guidance.
- Providing medical/scientific input and assisting with the preparation of regulatory submissions and responses to reviewers from regulatory agencies.
- Maintaining clinical, regulatory, and scientific expertise related to In-Vitro-Diagnostic (IVD) product development and regulatory documentation.
- Building and maintaining close relationships with external thought leaders and supporting the preparation of advisory boards within the assigned indication area.
- Building and maintaining relationships with international opinion leaders, investigators, and key customers, bringing external know-how in-house for the development of new products and innovative study designs.
- Building and maintaining strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders, and other alliance partners to meet business goals and ensure operational excellence.
- Supporting competitive differentiation, innovation, early pipeline activities, and development of intellectual property strategy.
- Supporting the management of external development partnerships (industry & academia).
- Navigating complex situations by applying a diverse skill set.
- Communicating difficult concepts and negotiating with others to influence different points of view.
- Driving patient and customer-centricity by prioritizing the needs of patients and customers.
- Supporting colleagues with less experience and helping them develop skills/expertise.
- Permanently optimizing processes to increase quality and efficiency standards.
Must Haves:
- Medical degree (Medical Director) or advanced degree in Life Science (PhD, preferably with experience in Neuroscience) with relevant expertise in the Healthcare Industry and/or academic institutions (experience in Neurology/Neuroscience preferred).
- 3 years (if Neurologist) or 5+ years (if PhD) academic, diagnostics, or pharma industry experience, preferably with IVD or Medical Device-related projects.
- Experience in regulatory submissions (IVDR/FDA).
- 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.
- Excellent communication and presentation skills in English.
- Ability to travel required up to 25% (can vary per project phase and position).
Role: Clinical Development Leader (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 100% (Hybrid)
Start: Asap or 01/12/2024
Duration: 12++
Job Type: 100%
Work Location: On the road
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