Nephrology Clinical Development Lead (f/m/d)

Nephrology Clinical Development Lead (f/m/d) – medical device study management / nephrology research / ICH-GCP / FDA / english

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Nephrology Clinical Development Lead

Background:

The nephrology clinical development lead is responsible for planning and implementation of clinical development activities for assigned products in nephrology.

You will design and implement a diagnostic strategy for nephrology, in close coordination with
the pharma division. Activities will predominantly focus on the disaggregation of diabetic kidney disease, early response markers of renally active molecules and strategies for identification of fast progressors.

You will be participating in the nephrology disease area community (DAC), a newly created matrix of colleagues across Pharma and DIA whose goal is to cure kidney disease by providing integrated solutions to address holistic chronic kidney disease patient needs. You will be responsible for initiating and leading specific diagnostic programs in alignment with the wider
DAC goals.

Tasks & Responsibilities:

• Building and maintaining strong, collaborative relationships with cross-functional leaders across Pharma and Diagnostics, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring scientific excellence
  *Preparing and leading advisory boards within nephrology
  * Substantial contribution to the clinical development strategy for nephrology
  *Driving competitive differentiation, innovation and early pipeline activities and develops intellectual property strategy
  *Developing and managing external development partnerships (industry & academia)
  *Designing scientifically sound clinical studies and study programs in cross-functional teams
  *Leading clinical study design and execution, including critical review of study results, protocol and report generation to support new product development
  *Leading comprehensive literature reviews, supervises collation of relevant clinical and scientific information from different sources, and creates new scientific content
  * Leading medical/scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies
  *Maintaining clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation
  * Participation in external interactions with health authorities (HAs)
  * 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
  * Permanently optimizes processes to increase quality and efficiency standards
  *Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first
  * Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity
  *Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial
  *Model Roche’s values of integrity, courage, and passion (culture, mindset and behaviors)

Must Haves:

• Medical degree or advanced degree in Life Science with relevant expertise in the Healthcare Industry and/or academic institutions
  *7+ years academic, diagnostics or pharma industry experience, preferably, having experience in IVD or medical device study management in all stages of global studies, development of study protocol design, report writing and leading matrixed teams
  *Experience in nephrology research or clinical development is a plus
  *Ability to lead clinical development studies/programs
  *Good knowledge in applicable standards and regulations (ICH-GCP, IVDD/IVDR, MDR, FDA,NMPA regulations etc) and understanding of the healthcare industry or equivalent academic experience
  *Strong business acumen; has in-depth knowledge of the multidisciplinary functions involved in a company’s development process, e.g., clinical operations, biostatistics, regulatory, commercial, etc. and can proactively integrate multiple perspectives into the clinical development process and strategy for best end-results
  *Excellent verbal and written communication, presentation and negotiation skills (English)
  * Excellent analytical skills and strategic mindset
  *Ability to work independently

Reference Nr.: 922254TP
Role: Nephrology Clinical Development Lead
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 80-100%
Start: 01.02.2023
Duration: 12++
Deadline: 19.12.2022

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.