Nephrology Clinical Development Lead

vor 3 Wochen


Zug, Schweiz Coopers Group AG Vollzeit

We are looking for a person who will be 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.

**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
- 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

**Requirements**:

- Medical degree or advanced degree in Life Science
- Minimum 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.

Sounds like a great job?

Find more vacancies at: coopers.ch

Coopers Group AG | Seestrasse 72b | CH-6052 Hergiswil NW | Tel. +41 41 632 43 50

**Job Profil**:

- Zug
- Contracting
- Vollzeit

**Klingt interessant?**
**Einfach klicken, dann melde ich mich.**:
Agnieszka Kawalec
Talent Acquisition Consultant



  • Zug, Schweiz Urovant Sciences GmbH Vollzeit

    **Position Description**: **Primary Responsibilities**: - The Director, Clinical Monitoring will be responsible for all aspects of monitoring and site management oversight for all of Urovant's CRO partners. He/she will work closely with Urovant's Clinical Operations Leads, Data Management, and QA, as well as with all involved functions and vendors (such as...


  • Zug, Schweiz Seagen Vollzeit

    Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are...


  • Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

    The Senior Clinical Project Manager/Associate Director, Clinical Operations will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the...

  • Lead Data Manager.

    vor 3 Wochen


    Zug, Schweiz PSI Vollzeit

    Job Description The Lead Data Manager is responsible for all data management activities in assigned clinical trials under supervision. Acts as primary communication point for project teams and company departments regarding clinical data management Acts as primary communication point for clients/vendors for all data management aspects of clinical...


  • Zug, Schweiz GSK Vollzeit

    **Site Name**: USA - Massachusetts - Waltham, GSK House, Switzerland - Zug, USA - Pennsylvania - Upper Providence **Posted Date**: May 16 2023 **Overview** The Global Medical Affairs Lead (GMAL) will be at the forefront of GSK’s re-emergence in discovering and providing cutting edge Oncology treatments. The person taking on this role will work closely...


  • Rotkreuz, Zug, Schweiz Roche Diagnostics International AG Vollzeit

    The Position As a Solution Development & Integration Sub-Chapter Lead, you will be a member of the Solution Development & Integration Leadership Team.  This is a Department Lead level position and requires experience in lab automation and in vitro diagnostics product development. In this Department Lead position, your role is to oversee and guide the...


  • Rotkreuz, Zug, Schweiz F. Hoffmann-La Roche AG Vollzeit

    The Position As a Solution Development & Integration Sub-Chapter Lead, you will be a member of the Solution Development & Integration Leadership Team.  This is a Department Lead level position and requires experience in lab automation and in vitro diagnostics product development. In this Department Lead position, your role is to oversee and guide the...


  • Zug, Schweiz Apellis Pharmaceuticals Vollzeit

    **Title: Associate Director, International Advertising and Promotion Regulatory Affairs** **Location: Zug or remote (Europe)** **Reporting: Senior Director, International Regulatory Affairs** **Description**: - The Associate Director of International Advertising and Promotion (A&P) serves as an internal expert on industry codes and guidance and...


  • Zug, Schweiz Urovant Sciences GmbH Vollzeit

    **Position Description**: The Executive Director Health Economics & Outcomes Research (HEOR) and Research and Development (R&D) International will develop the strategy and provide the internal expertise, guidance and oversight to the design, methodologies, analytic techniques and reporting of heath economic research and outcomes (HEOR). This will include...


  • Zug, Schweiz GSK Vollzeit

    **Site Name**: Cambridge 300 Technology Square, Switzerland - Zug, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence **Posted Date**: Feb 20 2023 **_ Key Responsibilities_**: - This role will provide YOU the opportunity to lead key activities to progress YOUR career, these...


  • Zug, Schweiz GSK Vollzeit

    **Site Name**: Cambridge 300 Technology Square, Switzerland - Zug, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence **Posted Date**: Feb 20 2023 **_ Key Responsibilities_**: - This role will provide YOU the opportunity to lead key activities to progress YOUR career, these...

  • Medical Monitor

    vor 4 Wochen


    Zug, Schweiz PSI Vollzeit

    Job Description PSI Medical Monitors  provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in Canada.  Responsibilities: Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on...

  • Medical Monitor

    vor 4 Wochen


    Zug, Schweiz PSI Vollzeit

    Job Description PSI Medical Monitors  provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in the United States Responsibilities: Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party...

  • Medical Lead, Alpine

    Vor 5 Tagen


    Baar, Canton of Zug, Schweiz Alexion Pharma GmbH Vollzeit

    Medical Lead, Alpine (Switzerland & Austria)Location: Baar, Switzerland Job reference: R-199140Date posted: 05.08.2024 Medical Lead, Alpine (Switzerland & Austria) Location: Baar  - Switzerland Reports To: Country Director, Alpine Dotted line to CENE Regional Medical Director This is what you will do: The Alpine Medical Lead is a member of the Alpine...


  • Zug, Schweiz Wellness Edge Pharmaceuticals Vollzeit

    We are looking for an ambitious Business Development Representative to join our team! As a Business Development Representative, you will be responsible for generating new business through outbound calls and social media referrals. Business Development Representative will be responsible for maintaining relationships with the end-users and community through...


  • Zug, Schweiz Blueprint Medicines Vollzeit

    Title**:Vice President, Medical Affairs International** Location(s): Zug, Switzerland Level of position: 12 Position type: office-based, in alignment with BlueFlex model* Reporting Line: The position reports to the SVP, Head of International **How will your role help us transform hope into reality?** Blueprint Medicines is on a journey to becoming a...


  • Zug, Schweiz GSK Vollzeit

    **Site Name**: Cambridge 300 Technology Square, Switzerland - Zug, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence **Posted Date**: Feb 20 2023 As a **Head of Business Development, Technology**, you will be a leader within the Business Development team, responsible for...


  • Zug, Schweiz Kenvue Vollzeit

    **EMEA Sustainable Packaging Lead**-2307008933W Description **EA Sustainable Packaging Lead**: **Locations: At our R&D sites in Switzerland, France, UK, Germany** **Who we are**: **At **Kenvue**, part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled...


  • Zug, Schweiz TD SYNNEX Vollzeit

    **Job Purpose**: To act as internal support to the vendor business lead to drive profitable market share growth through business planning execution, pipeline management and deep sales floor and customer enablement and engagement. **Responsibilities**: - Engages with the Business Unit and/or General sales floor, running desk training, tool training and...


  • Zug, Schweiz Exact Sciences Corporation Vollzeit

    Position Overview The Lead Counsel, International Corporate plays a leading role in complex commercial contracting and licensing matters, as well as business development activities outside the United States. The incumbent oversees the company’s ex-U.S. commercial contracting, including by managing other lawyers and liaising with the Company’s broader...