Senior Director Clinical Development & Scientific Affairs
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.
- 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
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.