Clinical Development Program Manager

Details

  • Category: Pharmaceutical
  • Location: Northern Switzerland
  • Starting date: Dec 02, 2019
  • Domain of experience: clinical development, medical affairs, clinical trials, clinical scientist, management, pharma
  • Level required: Program Manager
  • Years of experience: 5 - 8 years+

Your Role

We are looking for an expert in Clinical Development Program Management (Pharmaceuticals/Biotech) to join our experienced team of Consultants. We offer a permanent contract, development possibilities and cooperation with top life sciences companies in the world.

If you are a clinical development specialist, with experience in scientific & operational aspects and program & team management, do not hesitate and apply or contact us directly!

Your Tasks

  • Leads all clinical deliverables (clinical sections of individual protocols or sub-studies consistent with the Integrated Development Plans, clinical data review, program-specific standards, clinical components of regulatory documents/registration dossiers, and publications) in the assigned project or section
  • Oversees/conducts an ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
  • Takes responsibility for the development of clinical sections of trial and program level regulatory documents (i.e. Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
  • Manages the teams assigned to a program, including career development, performance management and talent planning processes, on-boarding, training, & mentoring
  • Supports Global Program Clinical Head in ensuring the overall safety of the molecule for the assigned section in collaboration with the Safety Management Team and Patient Safety
  • Supports the Therapeutic Area Head by providing medical input into IDP and CTP reviews and contributing/driving the development of disease clinical standards for new disease areas.
  • Braces interactions with external stakeholders (i.e., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards…) and internal stakeholders (i.e. Global Medical Affairs, Marketing…)

Your Profile

  • Advanced University Degree in life sciences/healthcare (or relevant), PharmD or PhD is a plus
  • Minimum of 5 years of involvement in clinical research or drug development in an academic or industry environment in clinical activities in Phases I through Phase IV
  • Experience in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in the pharmaceutical industry
  • Experience in oncology therapeutic area
  • Ability to establish a scientific partnership with key stakeholders
  • Strong background in GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process
  • People management experience (for the projects, in a matrix environment and/or global)
  • Excellent communication skills, written and oral
  • Fluency in English
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