Senior Director Clinical Development & Scientific Affairs job in Nyon, Switzerland

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: CRA Manager

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

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.

#LI-TR1

#Medical