Medical Director

Posted 15 November 2021
SalaryNegotiable
LocationBasel
Job type Limited
DisciplineScienceLife Sciences
ReferenceBBBH494659_1636998686

Job description

The world market leader in pharmaceutical industry is looking for a highly versatile and GCP versed MD personality with experience in psychiatric drug development, for its headquarter in Basel, Switzerland

Medical Director

The company`s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II - III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Medical Director participates in development of the Clinical Development (CD) strategy and plan and helps ensure effective and efficient CD plan execution for the assigned molecule(s)/indication(s). The Medical Director is an entry-level PD Medical Director position and, as such, Medical Directors are developing their knowledge of clinical studies and the pharma/biotech industry. Medical Directors participate in health authority (HA) interactions with supervision from more experienced PD Medical Directors.

Your tasks

Cross Functional

  • Participation in the relevant Clinical Science Team (CST) as well as ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution

Global Clinical Development Planning

  • Maintainig a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
  • As appropriate, participation in competitive intelligence and/or other market/industry assessment activities and projects
  • Collaboration with a variety of internal and external partners and stakeholders, (Clinical investigators, clinicians, scientists, KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, regulatory, business development, commercial operations, legal, etc.
  • Participation in CD strategy development
  • As assigned, consultation to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)
  • Participation in development of the CD plan for assigned molecule(s)/indication(s) and/or other programs
  • Support of other CST members in preparing for HA meetings. As appropriate, participation in HA meetings and representing the interests of Roche and patients

Clinical Development Plan Implementation

  • Design and development of clinical studies for review and discussion with other CST members
  • Development of product safety profiles
  • Development of clinical sections of investigator brochures, presentations and other materials
  • Probable participation in the identification and selection of appropriate external investigators and sites
  • Collaboration in the development of study analytics and data management plans
  • Participation in investigator and other external presentations, meetings and other communications
  • Probable medical monitor for assigned studies
  • Conducting of ongoing reviews of medical/safety data
  • Participation in the development and implementation of communications strategies to support existing and concluded studies
  • Working with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supporting others with clinical science information and input for regulatory submissions and other regulatory processes, including development of label and packaging language, etc.
  • Working with other CST members in ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs in the relevant therapeutic area of assignment

Your qualifications

  • D. with relevant medical experience in psychiatry (PTSD, anxiety disorders, schizophrenia)
  • Working knowledge of the US healthcare system (FDA) and versed in medical aspects of GCP and ICH
  • >2 years professional experience and understanding of drug development (phase II & III)
  • >2 years professional experience in working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g. ISS, ISE, competitor data, etc.)
  • >3 years professional experience developing product and safety profiles
  • Working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations
  • Pharmaceutical experience as an asset
  • Excellent English skills (oral/written)

Your application
Please apply online. For further information about the position, please contact your Kelly consultant, Mr. Andreas Danner, Dr. med. Dipl.-Biol. (+41 44 225 41 07/ +41 76 310 760 9)

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