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24.03.2020

Clinical Development Manager - Geneva

  • Switzerland - Meyrin/Geneva
  • Vollzeitstelle

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Clinical Development Manager - Geneva

Location: Switzerland - Meyrin/Geneva
Function: Clinical
Company: Vifor Pharma
Marilda Martins
Talent Acquisition Manager
+41 58 851 67 69
Apply
Agency policy
About you

In this new position, you report directly to the Head of Clinical Development. Your role is to support development, execution and management of clinical studies linked to worldwide clinical development plans for OM Pharma products. You act as expert on clinical and medical topics for other departments like Regulatory Affairs, Global Drug Safety, Medical Affairs and Marketing. Your responsibilities include:

  • Support the delivery of clinical development activities for the clinical programs at OM Pharma
  • Contribute in implementation of the development strategy
  • Ensure clinical studies are conducted effectively in partnership with Clinical Operations colleagues and CRO as appropriate
  • Contribute to clinical study teams in development and conduct of clinical studies
  • Support of development of study protocols, CRF's and provide scientific & medical input to SAP development through discussion with matrix team members
  • Participate in data review discussions and contribute to data interpretation
  • Support of authoring of clinical study reports and Investigator Brochures
  • Assist in producing materials for and organization of Investigator meetings
  • Support the preparation of regulatory briefing documents and clinical elements of regulatory submission documents (IND, CTA, NDA, BLA, MAA)
  • Administrative support to Medical Affairs team for investigator-initiated studies
  • Provide input into department SOPs and procedures as needed
  • Ensure that contract and invoices are processed in a timely manner

For this challenging position, we are looking for a person with strong scientific and structured reasoning bringing the following profile:

  • PhD or Masters degree in Biochemistry, biology or any other health-related discipline
  • 5 years’ experience within the pharmaceutical industry at a clinical trial support role
  • Previous experience in medical or health research is a plus
  • Demonstrated scientific credibility, and ability to input and influence projects through scientific and operational expertise
  • Strong knowledge of the drug development process and clinical trial execution
  • Strong knowledge of clinical trial documentation and regulatory requirements
  • Strong knowledge of ICH GCP requirements
  • Proficiency in MS Project or GANTT chart techniques is a plus
  • Fluent both in French and in English in oral and written conversation. Knowledge of Spanish or German is an asset

You hold very good communications skills and feel comfortable in a position where you have to present clinical research or scientific results to small and large groups. You describe yourself as a team player, who is able to understand different points of view and to perform in cross-functional teams. Thanks to your knowledge of the pharmaceutical environment, you make timely decisions that meet business’ needs and bring a solution and results oriented mindset that enables you to have innovative ideas.

You are looking for a new job opportunity in an agile and innovative company, where your flexibility and initiative spirit are seen as added values and encouraged.

 
About us

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.

Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.

The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are

Apply
Agency policy

Clinical Development Manager - Geneva

In this new position, you report directly to the Head of Clinical Development. Your role is to support development, execution and management of clinical studies linked to worldwide clinical development plans for OM Pharma products. You act as expert on clinical and medical topics for other departments like Regulatory Affairs, Global Drug Safety, Medical Affairs and Marketing. Your responsibilities include:

  • Support the delivery of clinical development activities for the clinical programs at OM Pharma
  • Contribute in implementation of the development strategy
  • Ensure clinical studies are conducted effectively in partnership with Clinical Operations colleagues and CRO as appropriate
  • Contribute to clinical study teams in development and conduct of clinical studies
  • Support of development of study protocols, CRF's and provide scientific & medical input to SAP development through discussion with matrix team members
  • Participate in data review discussions and contribute to data interpretation
  • Support of authoring of clinical study reports and Investigator Brochures
  • Assist in producing materials for and organization of Investigator meetings
  • Support the preparation of regulatory briefing documents and clinical elements of regulatory submission documents (IND, CTA, NDA, BLA, MAA)
  • Administrative support to Medical Affairs team for investigator-initiated studies
  • Provide input into department SOPs and procedures as needed
  • Ensure that contract and invoices are processed in a timely manner

For this challenging position, we are looking for a person with strong scientific and structured reasoning bringing the following profile:

  • PhD or Masters degree in Biochemistry, biology or any other health-related discipline
  • 5 years’ experience within the pharmaceutical industry at a clinical trial support role
  • Previous experience in medical or health research is a plus
  • Demonstrated scientific credibility, and ability to input and influence projects through scientific and operational expertise
  • Strong knowledge of the drug development process and clinical trial execution
  • Strong knowledge of clinical trial documentation and regulatory requirements
  • Strong knowledge of ICH GCP requirements
  • Proficiency in MS Project or GANTT chart techniques is a plus
  • Fluent both in French and in English in oral and written conversation. Knowledge of Spanish or German is an asset

You hold very good communications skills and feel comfortable in a position where you have to present clinical research or scientific results to small and large groups. You describe yourself as a team player, who is able to understand different points of view and to perform in cross-functional teams. Thanks to your knowledge of the pharmaceutical environment, you make timely decisions that meet business’ needs and bring a solution and results oriented mindset that enables you to have innovative ideas.

You are looking for a new job opportunity in an agile and innovative company, where your flexibility and initiative spirit are seen as added values and encouraged.

Vifor Pharma
Clinical

Arbeitsort:

Switzerland - Meyrin/Geneva

Marilda Martins
Talent Acquisition Manager
+41 58 851 67 69