Senior Director Clinical Development & Scientific Affairs

Highly Competitive
  1. Permanent
  2. CRA Manager
  3. Switzerland
Nyon, Switzerland
Posting date: 17 Aug 2020
31273

An exciting vacancy has arisen for a Senior Director of Clinical Development & Scientific Affairs to lead the team in Nyon. The talented individual will lead clinical parts of development to ensure an effective clincial study.

Job Responsibilities

  • Manages clinical due diligence for assigned projects assuring cross functional contributions as required according to the status and scope of the asset.
  • Manages clinical deliverables for assigned projects to allow optimized clinical document preparation after CSR and submission readiness, including but not limited to clinical module preparation.
  • Assures and manages all relevant clinical trial transparency activities according to the operating model.
  • Providing ownership of medical parts of clinical development for studies and programs
  • Taking clinical leadership role in meetings with the regulatory organizations required to outline the Company position on research programs regulatory applications and/or inspections.
  • Is accountable for the medical elements within CRO selection and RFPs and oversee respective tasks.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
  • Assures leadership in Medical writing activities


Skills and Requirements

  • Must be a Medical Doctor (M.D.)
  • At least 10 years of clinical experience mainly in the pharmaceutical industry preferably in biotechnology
  • Must have lead compound(s) to submission approval and through inspections with key agencies.
  • Ability to set priorities and following through including team management responsibilities and such related to the role within the organization
  • Hands on and entrepreneurial mindset
  • Ability to interact externally and internally to support a global scientific and Biosimilars business strategy.
  • Represent the organization appropriately with Agencies, external stakeholder



To Apply

In case you have difficulty in applying or if you have any questions, please contact Tom Russell on +44 203 8246 104 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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#Medical

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