Development Director

Basel-Stadt  ‐ Vor Ort
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Beschreibung

We are recruiting for a Clinical Development Director who will be involved in program level activities such as submission activities within Oncology.
Responsibilities:
  • Provide clinical leadership and strategic input for all clinical deliverables of the clinical program if applicable.
  • Be responsible for individual protocols or sub-studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
  • Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
  • Conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
  • Support in ensuring overall safety of the molecule and support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
  • Interact with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards


Requirements:
  • Medical Doctor or PhD with extensive experience in Industry/
  • 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
  • ? 3-5 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
  • Advanced knowledge of Oncology
  • Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process
  • The person will do routine clinical work ((medical) data review, study follow up, preparation of database lock, etc).


Kontakt: Luchele Mendes

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
02/2020
Dauer
09/07/2020
Von
Michael Bailey Associates
Eingestellt
10.01.2020
Projekt-ID:
1872430
Vertragsart
Freiberuflich
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