Clinical Development Leader in Hergiswil (NW)

This 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.

Duration: 1 year

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)

Requirements:

Medical degree (M.D) or PhD
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)

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Job Profil

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Contracting
Vollzeit
Immediately - 1 year

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Agnieszka Kawalec
Talent Acquisition Consultant
+41 41 632 43 54
Agnieszka.Kawalec@coopers.ch
m/w/d, Zug

Firma: Coopers Group AG

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