Clinical Pharmacology & Pharmacokinetics Manager (f/m)
im Bereich Forschung & Entwicklung, Klinische Forschung, Projektmanagement, Wissenschaftl. MitarbeiterIn
bei
NOXXON Pharma AG
NOXXON Pharma AG is a Berlin-based biotech company developing and producing Spiegelmers® as a novel class of therapeutics. We are now hiring a:
Clinical Pharmacology & Pharmacokinetics Manager (f/m)
Responsibilities:
The successful candidate will
- Conduct, contribute to, or supervise preclinical and clinical DMPK and PK/PD studies;
- Author/edit study protocols, reports and clinical pharmacology & pharmacokinetics sections of briefing books and other regulatory submission documents;
- Liaise with cross functional project team members in drug development to translate preclinical results to clinical success;
- Work across disciplines to select, develop, and implement PK/PD models in collaboration with CROs and external partners;
- Coordinate activities with internal bioanalytical department and manage the interface with CROs and external partners;
- Provide specific input into clinical trial management including CRF design to ensure complete collection of data required for proper PK/PD analysis;
- Run scientific literature searches and other research to support strategic overview planning and writing of proposals in support of individual clinical trials or for development programs.
Education and Experience:
- MD with an emphasis on clinical pharmacology & pharmacokinetics or PhD in Pharmaceutical sciences or a related field;
- At least 3 years of relevant industry or CRO experience;
- Broad understanding of clinical pharmacology, pharmacokinetics and PK/PD modeling strategies, preferably in the area of macromolecules (Noxxon products are parenterally administered oligonucleotides);
- Working knowledge of the fundamental principles of PK and PK/PD analyses for both preclinical and clinical studies;
- Familiarity and direct experience with common software tools for PK analysis (WinNonlin, NONMEM, SPLUS, etc.);
- Knowledge of bioanalytical methods and profound experience of statistics;
- Experience with respect to writing pharmacokinetic sections of preclinical and clinical study reports and data reviews;
- Excellent interpersonal, organizational, oral/written communication and teamwork skills;
- Project management experience is preferred.
Jobprofil
Stellentyp:
Fachkraft
Dienstsitz:
10589 Berlin
Region:
Berlin
,
Deutschland
Fachgebiet:
Biologie/Biotechnologie, Life Sciences, Medizin/Healthcare, Pharma
Berufserfahrung:
erwünscht
Auslandserfahrung vorausgesetzt:
Nein
GLP/GMP/GCP Kenntnisse erwartet:
Ja
Stellenlaufzeit:
unbefristet
Organisationsprofil
NOXXON Pharma AG is an independent biopharmaceutical company focusing on the development of innovative pharmaceutical products based on its unique proprietary Spiegelmer® Technology. The company is concentrating its attention on inflammatory diseases and haematological conditions. NOXXON's lead compound, NOX-E36 for treatment of kidney inflammation, is has successfully completed phase I clinical testing. A second Spiegelmer compound, NOX-A12 for use in hematopoietic stem cell transplantation and/or hematological or solid tumors, is in phase I clinical testing.
NOXXON's goal is the in-house development of our own Spiegelmer products through Phase II clinical trials. Complementing its own programs, NOXXON works on multiple drug discovery and development projects with its partners Eli Lilly and F. Hoffmann-La Roche. The pursuit of licensing partnerships and collaborative Research & Development efforts is an integral part of our business strategy and plays an important role in the company's growth and success. This strategy reflects our strengths in drug discovery and the vast potential of our unique technology platform.
Arbeitsgebiet:
Klinische Forschung
Pharmaindustrie
Wissenschaftl. Forschung
Expansion:
International
Mitarbeiteranzahl:
51-500
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