Clinical Development Director Cardiorenal - Zurich

Employer
Vifor Pharma
Location
Glattbrugg, Switzerland
Salary
Competitive
Closing date
16 Oct 2020

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Discipline
Clinical Research, Clinical Development
Hours
Full Time
Contract Type
Permanent
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About You
Due to its expanding portfolio, Vifor Pharma has an excellent opportunity for a Clinical Development Director for our cardiorenal therapy area. This role will be a part of our global clinical development team based in Glattbrugg, Zurich.

Reporting to the Clinical Development Lead for Cardiorenal, the Clinical Research Director will be responsible for medical and scientific contribution to protocols, new product and indication opportunities, drug safety, study reports, IBs, regulatory submissions, manuscripts, medical education, and other projects requiring medical/scientific research, analysis, evaluation, training and reporting.

Key responsibilities (but not limited to):

  • Leadership of clinical study/program to ensure delivery of clinical trials per ICH-GCP requirements and meeting timelines and budget


  • Leadership and moderation of clinical advisory boards and ongoing interactions with applicable committees relevant to successful conduct of studies and programs


  • In collaboration with a cross-functional team, drive the development of effective and innovative clinical trial designs, and facilitate execution of clinical trials by supporting site and CRO personnel, safety monitoring activities, data clean-up activities, data analyses, and clinical study report development and finalization


  • Author protocols, and provide scientific input into manuscripts/publications, IBs, regulatory and study reports


  • Research and analyse scientific/medical information and data with respect to clinical trials, safety databases, and other medical/scientific elements necessary for decision-making and regulatory submissions


  • Assess safety data including labs and SAEs on an ongoing basis for ongoing clinical trials; manage DSMB processes for clinical trials


  • Represent the company as the scientific subject matter expert at external meetings including those with Investigators, Steering Committees, Key Opinion Leaders and Advisory Groups


  • Provide Medical Oversight and Medical Monitoring to interventional clinical trials (supported by CROs, if applicable)


  • Maintain and evaluate current knowledge of key disease areas, providing information to appropriate groups as needed


  • Evaluate investigator-initiated protocols and make recommendations (if applicable)


Requirements:

  • Educational background: MD (strongly preferred) or internationally recognized equivalent degree or PhD in science/health-related discipline


  • 6 to 8 years of pharmaceutical industry experience gained in clinical research


  • Experience in phase 3 and 4 clinical studies/outcomes trials is an advantage


  • Knowledge and experience of clinical trial design, data analysis, statistics and research methods


  • Knowledge of the drug development process and clinical research methodologies


  • Trained in GCP regulations, and familiar with ICH and FDA guidelines relevant to clinical development


  • Experience in Cardiology and/or Nephrology clinical trials would be preferrable


  • Experience in writing and submission of Health Authority documents (e.g., NDA, sNDA, MAA) desired


  • Ability to work independently and in a fast paced, hands-on, flexible, dynamically changing environment


If this opportunity is of interest to you, please apply by submitting your updated CV via our careers website.

About Us
The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.

Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit www.viforpharma.com/career

We are looking for new people to join an international team of more than 2,700 talented people, operating in over 100 countries to support our Vision of becoming global leader in our three therapeutic areas:

IRON DEFICIENCY

 

NEPHROLOGY

 

CARDIO-RENAL

 

WHY VIFOR PHARMA

We are a global leading expert in iron deficiency and iron deficiency anaemia.

We are proud of a broad portfolio to help nephrology patients suffering from kidney disease.

Our expertise in both these areas are helping cardio-renal patients.

We innovate internally, but we also partner with the best companies externally. We are also a unique pharmaceutical company, as we have direct access to Fresenius Medical Care clinics via our joint company. Fresenius Medical Care has access to more than 329,000 patients in its global network of over 3,900 dialysis clinics.

Contact Us
  • Flughofstrasse 61
  • 8152 Glattbrugg
  • Switzerland
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