Clinical Development Leader (m/f/d)
Infos sur l'emploi
- Date de publication :04 octobre 2024
- Taux d'activité :100%
- Type de contrat :Temporaire
- Langue :anglais (Courant)
- Lieu de travail :Rotkreuz
For our long-standing and well-known business partner, Roche Diagnostics Schweiz AG, based in Rotkreuz, we are looking for a motivated and committed Clinical Development Leader for a temporary assignment of 12 months with the option to extend.
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.
Tasks
- 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
- Travel up to 25%
Must Haves
- Bachelor's degree in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate
- Preferably experience in clinical research or laboratory research
- Min. 2 years of prior relevant experience
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
- Excellent oral and written communication skills in English
- Excellent planning, organizing, and interpersonal skills
- Ability to work independently, make sound decisions, and to analyze and solve problems
- Medical laboratory experience preferred
- Good therapeutic and protocol knowledge
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
- Organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Nice to Have
- Experience in Pathology
Are you interested? Don't hesitate and send us your complete application documents online today.
We will also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!
Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.
Kontakt
Andreas Zgraggen
Arbeitsort
Rotkreuz
Pensum
100%
Position
Mitarbeiter
Branche
Pharma + Chemie + Life Science
Contact
Work Selection