Carrer

The future is waiting for you!

We owe our success to the people who work for us.

With its products and services CO.DON sustainably improves the health and quality of life of its patients. Our innovative products and working methods would be unthinkable without motivated, qualified and team-oriented colleagues.

As an innovation leader in the highly dynamic regenerative medicine market we are looking for the best; people who will prosper in our creative working environment and make our corporate goals their own career goals.

CO.DON AG
Human Resources
Warthestrasse 21
14513 Teltow
karriere[at]codon.de

 

VP Global Medical Affairs

Berlin-based biopharmaceutical company CO.DON develops, produces and markets in Germany autologous cell therapies for the minimally invasive repair of cartilage damage to joints following traumatic or degenerative defects. The cell based autologous product has been used to treat more than 10,000 patients up to now. The company is currently undergoing Phase II and III clinical trials to obtain European marketing authorization which is expected in second half of 2017.

For our Medical Affairs Department we are looking for a

VP Global Medical Affairs

Key Responsibilities

  • Managing Key Opinion Leader (KOL) Relationship, professional societies and other key stakeholders.
  • Managing publication strategy from corporate sponsor trials
  • Oversees and assumes responsibility for the planning, timely implementation, and tracking of all activities of the office-based and field-based Medical organization to ensure full and appropriate utilization.
  • Integrates medical and scientific insight into regional strategies, plans and tactics.
  • Establishes a close, effective and efficient network of external and internal contacts to monitor and influence the development of medical-scientific opinions and beliefs as well as medical practice
  • Develops and oversees a mechanism by which scientific opportunities and data identified by the field-base
  • Develops and effectively manages annual operating plan and budget for management of the Medical Affairs organization
  • Presenting educational information about therapeutic landscape
  • Review and approve all medical, technical and promotional materials
  • Partner with Market Access and Commercial to co-ordinate medical input into local appraisal documents & strategy

Your Profile

  • Medical Doctorate (M.D.) degree with completion of residency and/or fellowship in the Orthopedic field is preferred.
  • Minimum of 5 years of Medical Affairs with a track record of connecting the scientific data to patients, business solutions resulting in memorable experiences for patients and all stakeholders.
  • Track record of connecting and developing trustful relationships with internal and external stakeholders to accelerate business achievements and leveraging diversity to improve outcomes. Connected externally with consortia and thought leaders driving win-win innovative patient solutions.
  • Good knowledge of clinical trial methodology, regulatory requirements governing clinical trials.
  • Excellent medical knowledge, general as well as focused on the orthopedic field
  • Professional experience in the planning and conduct of clinical research Projects
  • Profound knowledge of health care policy and health economy
  • Proven presentation and moderation skills
  • Good command of German & English
  • Pref. based in Germany, Berlin.

 We offer you

  • To be part of a dynamic, passionate, work hard/play hard team.
  • Create your own exciting career opportunities in an international growing company.
  • To incentivize your already attractive salary with high performance bonus pay outs.

 Please send a full application package (CV, cover letter, certificates and references) by E-Mail to Mr. Dirk Hessel, CEO: d.hessel@codon.de

 

Director Pharmacovigilance (f/m)

Berlin-based biopharmaceutical company CO.DON develops, produces and markets autologous cell therapy products for the repair of cartilage damage to joints following traumatic or degenerative defects. These advanced therapy medicinal products (ATMPs) are produced and distributed according to GMP and AMG.

For the Teltow site (directly at Berlin city limits), we are looking for an experienced and motivated Director Pharmacovigilance.

Key Responsibilities (m/f)

  • Development, optimization and maintenance of the pharmacovigilance system according to European guidelines (GVP)
  • Implementation of European pharmacovigilance system, including international "Responsible Person for Pharmacovigilance" in the various EU countries and, e.g. reporting of cases, revision / creation of local SOPs
  • Collection, analysis, evaluation and processing of individual case safety reports and preparation of pharmacovigilance-related documents, e.g. Risk Management Plan and Pharmacovigilance System Master File PSMF, maintenance of data bases
  • Complaint handling
  • Communication about safety concerns between CO.DON and national/international competent authorities, preparation of Safety Update Reports (PSUR, DSUR)
  • Meeting commitments and responding to requests from competent authorities
  • Planning and conducting external and internal audits/inspections
  • Communicating information (national/international) to competent authorities, heath care professional, patients and external partners
  • Pursuing and implementation of pharmacovigilance legislation for medicinal products

Your Profile

  • University degree in natural sciences/medicine, ideally in the field of orthopedics, biologicals or borderline products
  • Several years of experience in pharmacovigilance (national/international)
  • Qualified and trained for EEA-QPPV (EU level and AMG)
  • Distinct team spirit and excellent communication skills
  • Business fluent English and German skills (spoken and written)
  • Self-reliant, dedicated and structured working style as well as a solution-oriented and pragmatic approach

Please send your complete application (cover letter, CV, certificates and references) to c.kaps@codon.de