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Toxicologist – Drug Safety Group Leader

  • Warszawa, mazowieckie pokaż mapę
  • Kierownik
  • 08.11.2017

Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

OncoArendi Therapeutics SA

OncoArendi Therapeutics (OAT) is an innovative biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics for inflammatory diseases and cancer. OncoArendi's business model is strictly focused on drug discovery and development, with its core strength in high quality medicinal chemistry, discovery biology and preclinical and early clinical development, enhanced by scientific collaborations with key opinion leaders in specific disease areas and prudent use of CROs.

Toxicologist – Drug Safety Group Leader

Workplace: Warszawa
Region Name: mazowieckie

Responsibilities

  • Design and implementation of non-clinical safety assessment programs supporting clinical development of OAT drug candidates.
  • Monitoring overall preclinical safety assessment activities.
  • Overseeing of nonclinical studies conducted at CROs.
  • Leadership role, problem-solving of technical issues related to non-clinical studies.
  • Designing the study protocols conforming to regulatory requirements related to nonclinical studies. Conducting reviews of draft report of non-clinical studies, deriving interpretations form available data and design of subsequent experiments.
  • Reviewing of IMPD & IB parts referring to non-clinical studies.
  • Maintaining current technical knowledge and skills, and applying them in every day duties.
  • Representing the company during interactions with CROs, external consultants, etc.

Qualifications

Education and Experience Required:

  • PhD in Veterinary Medicine, Biology or a related discipline as well as five (5) years of relevant experience, OR a Master’s degree in Veterinary Medicine, Biology or a related experience supplemented by ten (10) years of relevant experience.
  • Preferred pharmaceutical industry experience as a non-clinical safety assessment scientist.
  • Working knowledge of animal physiology and pharmacology.
  • Ability to independently design and execute non-clinical studies (i.e.: toxicology studies, PK studies).
  • Understanding of regulatory guidelines (i.e., OECD GLP, FDA GLP) and regulatory/quality compliance requirements.
  • Strong interpersonal and communication skills, both oral and written.
  • Highly dedicated, motivated, resilient and flexible; capable of creative problem solving and delivering on goals and objectives in a timely fashion in a scientific business model setting.
  • Excellent team player who is able to work collaboratively with team members from various functions.

Significant Work Activities and Conditions:

  • Job Classification: Experienced
  • Primary Location: Warsaw, Poland
  • Organization: Research & Development
  • Schedule: Full-time
  • Travel: Yes, 10 % of the Time
We offer:
  • Opportunity to develop new skills within drug development field
  • Medical package
  • Good atmosphere at work

If you are interested, please send your CV via Aplikuj button below.

Please include the following statement in your application: "I hereby consent to processing by the advertiser of my personal data, included in my application documents, for the purposes to implement the recruitment process according to the act of 29 August 1997 on personal data protection (consolidated text: Journal of Laws of 2016, pos. 922). I also consent to processing of my personal data by the advertiser for the purposes of any future recruitment processes."


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