Global Medical Affairs Lead, Hematology, Open to flexible working
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 Clinical Development, Commercial, Local and Regional Teams to formulate and execute a world class Global Medical Affairs hematology disease area strategy, with focus on those areas outside Blenrep asset plan. Besides this, this person will act as the hematology global medical team physician (including Blenrep) for reviewing compassionate use/early access program patient eligibility and approval. It is expected that this role will broaden in due course to cover molecules forthcoming through pipeline progress and business development projects.
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.
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 hematology disease area strategy
- 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.
- BD and Due Diligence support for hematology assets
- 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
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 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.
- MD degree, 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 experts
- Hematology therapeutic area experience.
- Experience of building a sustainable credible external expert network with world leaders in the relevant fields of science and medicine
- Thorough understanding of medical affairs evidence generation expectations and product development life cycle
- Thorough knowledge of clinical trial concept generation and set up
- Thorough understanding of medical affairs educational needs and patient advocacy group engagements
- Experience of across franchise prioritisation
- Demonstrable cross functional matrix leadership skills.
- Strong stance on compliance and awareness of local, regional and global regulations relating to the development and launch of Pharmaceutical products.
- Strong collaboration and partnering skills.
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, colour, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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