Clinical Development Leader (m/f/d)

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 also defines the clinical product specifications, development strategies, and clinical study designs for product registration with adept medical writing, regulatory, and safety expertise.

This particular position is within the Clinical Development NEO (Neurology, Endocrinology and OBGYN) subchapter. The position focuses on Neurology where the Clinical Development Leaders share the common goal of developing 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. Furthermore the candidate has sound knowledge in neurodegenerative diseases as well as 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, cohesively collates relevant clinical and scientific information from different sources, and creates new scientific content with minimal guidance/direction
* Providing medical/scientific input and assists with the preparation of regulatory submissions as well as responses to reviewers from regulatory agencies
* Maintaining clinical, regulatory, and scientific expertise as it relates to In-Vitro-Diagnostic (IVD) product development and regulatory documentation
* Building and maintains close relationships with external thought leaders, supports 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, in meeting business goals and ensuring operational excellence.
* Supporting competitive differentiation, innovation and early pipeline activities and development of intellectual property strategy
* Supporting managing external development partnerships (industry & academia)
* Navigating in complex situations by applying a diverse skill set
* Communicating difficult concepts and negotiates with others and influences to adopt a different point of view
* Driving patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first.
* Supporting colleagues with less experience and helps them develop skills/expertise
* Permanently optimizes processes to increase quality and efficiency standards

Must Havs:

* Medical degree (Medical Director) or advanced degree in Life Science (PhD preferably if experience in Neuroscience) with relevant expertise in the Healthcare Industry and/or academic institutions (experience in Neurology/Neuroscience preferred)
* 3 years (if Neurologist) resp. 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)


Reference Nr.: 923692SDA
Role: Clinical Development Leader (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 100% (Hybrid)
Start: Asap or 01/12/2024

Duration: 12++

Travel: Upto 25%
Deadline: 09.10.2024

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