Foundation Medicine South HUB Medical Manager

Argentina, Buenos Aires

The Foundation Medicine South HUB Medical Manager (Argentina, Chile and Uruguay) is a key strategic leadership role requiring therapeutic area expertise and clear business understanding to identify and address the relevant medical needs of clinical practice, to successfully support the optimal use of Roche/Foundation Medicine Services.

 

The Foundation Medicine South HUB Medical Manager:

  • links affiliates to LATAM/Global Medical Affairs objectives to deliver on data generation, knowledge exchange / data communications, and to lead TAE engagement in a scientific manner.
  • acts as a guardian for high standards of compliance, ethics, and safety of Roche/Foundation Medicine Services, putting patients at the center of his/her actions.
  • Establish long-term, peer-to-peer relationships with TAEs and investigators and deliver quality interactions and services  that bring value to physicians, and that are aligned with Roche/ Foundation Medicine Services.
  • Identify opportunities for collaborations between the company and the TAEs and investigators.
  • A part-time field-based resource for TAEs and investigators delivering  the scientific information that they require in the context of their work, in accordance to local laws, regulations and codes, and Roche/Foundation SOPs

Responsible for:

  • Development of the South HUB Medical Plan
  • Medical expertise and customer insights to the Brand team
  • Design, oversight of execution, and report of clinical trials according to ICH-GCP, Roche SOPs and local regulations
  • Development of effective interactions with Clinical Operations (both PDG and PA/GPS), including but not limited to placing studies, provide input on feasibility, sites and investigators selection.
  • TAE engagement plan to support medical objectives: identification, development, and establishment of scientific relationship with TAEs.
  • Interacting with HCPs to understand their views, preferences and interests, in the assigned therapeutic area, and where Roche / FMI can partner with them to meet their needs where aligned with our strategies.
  • Providing medical expertise to HCPs, and HCP insights  to internal product  teams.
  • Support for PharmacoVigilance activities, including assurance of appropriate adverse event reporting in coordination with LSR.
  • Support for Regulatory and Medical Information activities for selected products.
  • Medical and regulatory clearance of promotional and informational materials

Key Activities:

  • Development and management of the medical plan
  • Identify local data gaps, local studies protocol design, study planning (including budget), input to site selection and feasibility assessment, data dissemination strategy
  • Align the regional medical plan with the regional marketing, CT/IMT/DST strategy and global medical plan, under supervision of Medical Director and FMI MA LATAM Manager
  • Congress overview and guidelines development

Medical expertise and customer insights to the brand team:

  • Offer expert opinion aligned with LCT/IMT/DSC medical recommendations on scientific medical information to identify and develop effective peer-to-peer relationships to execute Foundation Medicine strategies, while holding high ethical standards, compliance to Roche SOP and local/international regulations
  • Research, collate, present and offer data insights related to Foundation Medicine services
  • Manage the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes.
  • Manage Medical Information activities in accordance with regional/local model, referencing global standard responses.
  • Manage publication related activities according to Roche Policy and SOPs
  • Develop a customer centricity culture, making sure promotional/medical/scientific communications address HCP needs and optimize patient benefit and safety while keeping a fair balance and compliance with regulations and SOPs
  • Contribution to local clinical operations activities
  • Oversee the phase III-B/IV trial program by holding effective relationship with the Clinical Operations team
  • Inform other Affiliate functions on Global planned studies
  • Design and implementation of patient support programs

TAE engagement plan and execution:

  • Maintain regular contacts with investigators for key studies
  • Identify and develop scientific relationship with external TAEs/ experts who are qualified sources of insight and advice
  • Ensure that all activities towards external experts / TAEs are harmonized across the affiliates
  • Share Best Practices across customers to facilitate improved patients outcome
  • Planning and execution of relevant scientific advisory boards and expert meetings
  • Interact with HCPs to understand their views, preferences and interests and where Roche / GNE can partner with them to meet their needs where aligned with our strategies
  • Participate/support the CMMs in the execution of regional advisory boards
  • Acquire physician perspectives on competitive services / clinical studies
  • Provide support to speakers on the development of materials