Global Clinical Leader, Snr.

Global Clinical Leader, Snr.
  • £150,000 - £170,000 per Annum
    ANNUM
  • Permanent
  • Spain 08001 Spain 08001
Job Ref: J2164535
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 22 April 2022
Truly exciting Clinical Development Opportunity. The pipeline is full of innovation and company commitment to development is solid.

Detailed Job Description

Tasks and Responsibilities

  • Defines the clinical strategy, milestones and resources required to meet development decision points/Target Product Profile TPP), Target Product claims (TPC) and target labeling
  • Permanent member of the Project Core Team, representing Global Clinical Development.
  • Leads/chairs the Medical Sub Team (MST).
  • Provides guidance to Clinical Study Teams to ensure alignment of clinical trials planning and conduct with the overall development strategy.
  • Review and approves (when applicable) key clinical trial documents (e.g. protocol, SAP, CSR).
  • Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and products in compliance with GCP
  • Ensure internal and external peer review of potential study/program design.
  • Responsible for clinical content for key internal or external project related documents (eg. IB, briefing package for regulatory authorities, ISE, ISS, publication).
  • Identifies and manages the Clinical risks and opportunities.
  • Represents Company as the project clinical expert at meetings with regulatory agencies.
  • Represent Company at meetings with external scientific fora, clinical investigators and other clinical personnel.
  • Primary contact for Global Marketing & Medical Affairs to define the Market Access needs and clinical differentiation strategy.
  • High level of strategic external interactions, including academic collaborations, external experts & key centers, including delivery of Advisory Boards.
  • Provide clinical/scientific input to in-licensing opportunities.

Education and Experience

  • MD degree
  • Significant hands-on clinical drug development experience and scientific credibility
  • Significant Experience in Clinical Development and regulatory submissions
  • Expertise in Dermatology and/or Immunology/Internal medicine/Rare indications
  • Experience in similar projects with biotech or pharmaceutical companies

Skills

  • Proven teamwork and collaboration skills
  • Strategic Leadership.
  • Demonstrated success influencing functions outside of clinical and across geographies
  • High presentation skills.

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
22/05/2022 12:28:57
GBP 150000.00 170000.00 Annum
Contact Consultant:
Vlad Babych

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