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Program Manager Oncology Access and Compliance

2 months ago

Dubai, Dubai, United Arab Emirates GSK Full time
Job Summary

We are seeking a highly skilled and experienced professional to join our team as a Program Manager Oncology Access and Compliance. This role will be responsible for providing operational leadership for GSK's oncology expanded access/compassionate programs.

Key Responsibilities
  • Operational Leadership: Provide strategic direction and oversight for GSK's oncology expanded access/compassionate programs, including plans and strategies for footprint, drug supply, regulatory coordination, physician oversight, vendor set up and management, safety reporting, and other related activities in accordance with GSK Policies and SOPs.
  • Vendor Management: Oversee the management of vendors associated with access programs, ensuring compliance with GSK's vendor management policies and procedures.
  • Program Operations: Set up operations to ensure rapid response to requests from physicians regarding patient access to EAP/CU programs, including coordination with internal stakeholders and external vendors.
  • Status Updates: Provide regular status updates on program utilization to internal stakeholders, ensuring transparency and accountability.
  • Operational Input: Provide operational input and assistance when required, supporting the development and implementation of access programs.
  • Stakeholder Relationships: Establish and maintain strong relationships with all stakeholders, including Global Medical Affairs colleagues, LOCs, physicians, program managers, regulatory and safety teams.
Requirements
  • Education: BSc degree in a life science related field.
  • Experience: Four or more years of demonstrable, varied, and progressive experience in a professional scientific or clinical role, either in Medical Affairs/Clinical Operations or at a relevant institution or vendor.
  • Program Management: Two or more years of experience managing an individual compassionate use program or Expanded Access Program, or proven experience managing clinical research studies in a professional setting.
Preferred Qualifications
  • Oncology Experience: Oncology medical or scientific experience highly desired.
  • Vendor Management: Experience managing vendors.
  • Protocol Design: Demonstrated knowledge of protocol design in oncology studies.
  • Project Management: Strong planning and project management skills.