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16292en
- Contract
- English
- Mid-Senior level
- Research & Development
- Zug
- Healthcare & Life Sciences
Skills
Neurology, Alzheimer's, Parkinson's, clinical development, research, regulatory submissions, clinical study design, scientific writing, healthcare
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On behalf of our client, a leading international pharmaceutical company, Swisslinx is looking for a Clinical Development Lead. If this is you, you will be part of a team developing diagnostic solutions to address unmet medical needs in Neurology, especially in Alzheimer’s, Parkinson’s Disease, and Multiple Sclerosis.
Contract type - 12 months (extension possible)
Start Date – December latest
Location - Rotkreuz, near Zug
Workload - 100%
Work type - hybrid possible (2-3 days campus)
Your mission:
• 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
Your background:
• The perfect candidate is either a Medical Director or PhD with around 5 years of experience in Clinical Development / Clinical Science, with sound knowledge in neurodegenerative diseases as well as experience in regulatory submissions (IVDR/FDA).
• 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) (MANDATORY)
• 3 years (if Neurologist) resp. 5+ years (if PhD) academic, diagnostics or pharma industry experience, preferably with IVD or Medical Device related projects (MANDATORY)
• Experience in regulatory submissions (IVDR/FDA) (MANDATORY)
• Good understanding of clinical development including clinical study design and scientific writing experience as well as leading matrixed teams (MANDATORY)
• Detailed understanding of the healthcare industry or equivalent academic experience (MANDATORY)
• Excellent communication and presentation skills in English
• Ability to travel required up to 25% to US and EU (can vary per project phase and position)
What's on offer
• An initially 12 month contract, with likely extension,
• A chance to develop your career at an internationally renowned pharmaceutical company.
• A competitive salary.
• A flexible hybrid working policy.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.
Contract type - 12 months (extension possible)
Start Date – December latest
Location - Rotkreuz, near Zug
Workload - 100%
Work type - hybrid possible (2-3 days campus)
Your mission:
• 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
Your background:
• The perfect candidate is either a Medical Director or PhD with around 5 years of experience in Clinical Development / Clinical Science, with sound knowledge in neurodegenerative diseases as well as experience in regulatory submissions (IVDR/FDA).
• 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) (MANDATORY)
• 3 years (if Neurologist) resp. 5+ years (if PhD) academic, diagnostics or pharma industry experience, preferably with IVD or Medical Device related projects (MANDATORY)
• Experience in regulatory submissions (IVDR/FDA) (MANDATORY)
• Good understanding of clinical development including clinical study design and scientific writing experience as well as leading matrixed teams (MANDATORY)
• Detailed understanding of the healthcare industry or equivalent academic experience (MANDATORY)
• Excellent communication and presentation skills in English
• Ability to travel required up to 25% to US and EU (can vary per project phase and position)
What's on offer
• An initially 12 month contract, with likely extension,
• A chance to develop your career at an internationally renowned pharmaceutical company.
• A competitive salary.
• A flexible hybrid working policy.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.
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