Global Medical Affairs Leader, Synthetic Lethality

Site Name: Baar Onyx, GSK House, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence

Posted Date: Mar

The Global Medical Affairs Lead (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 their peers in Clinical Development, Clinical Research and Commercial to formulate and execute a world class Global Medical Affairs synthetic lethality strategy. This person will be directly responsible for leading the Synthetic Lethality program.

The strategic role is accountable for developing the synthetic lethality strategy inclusive of scientific communication strategy, training plans, synthetic lethality alliances, guideline strategy, investigator sponsored studies and areas of interest, Phase IIIb and IV evidence generation studies, including post-approval commitments and health outcomes studies. Working in close partnership with R&D, you will deliver the evidence needs for the assets and will be accountable for developing and delivering the Integrated Evidence Generation Plan (spanning late stage development and post launch market access support). You will engage in scientific exchange with external experts and will lead efforts to rebuild the GSK Oncology medical presence with our stakeholders. You will be a member of both the Medicines Development Team in R&D and the Medicines Commercialisation Team. You will act as the single voice of Medical Affairs for synthetic lethality, into R&D and Commercial.

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:

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 - C2MD- 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 asset strategy, Global alignment and differentiation plan for the asset
• Develops evidence plans (in partnership with R&D).
• Leads the global scientific engagement strategy for the asset and is an external speaker for GSK at scientific congresses or other company organised events.
• 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.
• Responsible for Integrated Strategic Medical Plan for synthetic lethality assets
• BD and Due Diligence for synthetic lethality assets

Application of Knowledge

• Leads and Embeds Medical Governance.
• Evaluates local data needs for assets in partnership with relevant stakeholders locally (core countries).
• Formulates strategies for the asset and develops evidence plans (in partnership with R&D).
• Execution of phase IIIB -IV studies, in addition to post-approval commitments, if applicable.
• Leads the global scientific engagement strategy for the asset.
• Seeks relevant scientific / medical insight from stakeholder groups, including governments.

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 (including governments).
• 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 teamworking.

Impact

• Decision-making on strategic plans.
• Single voice of Medical to R&D and Commercial for the asset.
• Senior most Medical Affairs leader dedicated to the synthetic lethality Franchise. Medical Governance oversight to ensure focus on patient.
• Key external face of GSK for a medicine in development.
• Contributes synthetic lethality asset evaluation

Candidate profile:

• MD, PharmD or PhD with strong experience in oncology and specifically synthetic lethality.
• Prior Global Medical Affairs leadership experience
• Prior in country medical affairs leadership experience
• Experience with Pre-Launch medical affairs activities.
• Oncology drug development experience.
• Experience of leading a matrix team.

Preferred: Board certified oncologist

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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