Global Medical Affairs Lead, Hematology

Overview

Momelotinib was recently approved by the FDA, received positive CHMP opinion and expects EMA approval in the next few weeks and will be followed by multiple approvals worldwide, for treating patients with myelofibrosis that suffer from anemia.

For this asset, we at GSK are recruiting a Global Medical Affairs Lead (GMAL). The GMAL will be at the forefront of GSK’s re-emergence in discovering and providing cutting edge Oncology treatments. The person taking on this role will work closely with Clinical Development, Commercial, Local and Regional Teams to formulate and execute a world class Global Medical Affairs hematology disease area and asset strategy.

The GMAL will lead a team of medical and scientific directors dedicated to advancing science and improving the outcome of patients.

The role requires deep scientific understanding of the disease area and emerging treatment options, business acumen and strategic thinking to leverage this understanding for development of the disease area strategy, and cross-functional planning, including clinical development and business development strategies. This person will engage in scientific exchange with external experts and will lead efforts to rebuild the GSK Oncology medical presence with our stakeholders. This is a highly visible, influential leadership role, requiring excellent networking, communication and influencing skills to work effectively in a highly matrixed environment.

Key responsibilities:

Impact

• Lead a group of medical and scientific directors dedicated to an asset and/or disease area in hematology
• Chairs the Global Medical Affairs Team for the specific asset/disease and the Medical Review Committee for related evidence generation proposals
• Decision-making on strategic plans.
• Patient eligibility approvals for early access/compassionate use programs
• Medical Governance oversight to ensure focus on patient.
• Key external face of GSK for a medicine in development.
• Contributes to hematology asset evaluation

Safety and efficacy evaluation and optimization

• Gather medical insights from the field medical team, patient advocacy, in-country GSK experts, and key external stakeholders to inform and shape product strategy and to be accountable for the development of the integrated evidence strategy and plan (from Commit to Medicine Development onwards).
• Work in partnership with central teams, to optimize plans in support of a reimbursable file and life cycle strategy.
• Accountable for the execution of phase IIIb and IV studies, including post-approval commitments, if applicable.
• Evaluates local data needs for assets in partnership with relevant stakeholders locally (core countries).
• Responsible for hematology asset & disease area strategy & plan
• Leads the global scientific engagement strategy.
• Seeks relevant scientific / medical insight from stakeholder groups.
• Lead the external engagement plan and develop strong relationships with external stakeholders.
• Lead and implement global scientific engagement program including development and maintenance of Scientific Platform and ensure medical governance.
• Accountability for the medical ABPI certification of launch materials and activities to ensure they are compliant with GSK SOPs and external industry standards.
• Business Development and Due Diligence support for hematology assets

Problem Solving & Innovation

• Identifying gaps and opportunities from the complexity and volume of data emerging from the countries.
• Consolidating the information into one coherent strategy that is supported by key internal business stakeholders.
• Resolving issues with regulators/governments and negotiating appropriate needs and strategies to develop evidence for the asset.
• Ensuring appropriate interaction and exchange of scientific information in adherence with scientific engagement principles and standards, locally and globally.

Interaction

• Interaction with external stakeholders.
• Discussing current and emerging treatment management issues, treatment evolution, guidelines, and health policies
• Discussing scientific issues related to clinical development, study design, data interpretation, study conclusions, and protocol recommendations
• Job involves interface with a very wide range of stakeholders internally and externally, and this requires a strong listening and communication skills, and collaborative team working.

Candidate profile:

• Medical Doctor, with hematology/oncology training
• Medical Affairs experience at the global level including strategic planning and product launch
• In country medical affairs experience working with local payers and medical exper