Global Medical Affairs Lead - Otilimab LCM, Open to flexible working

Location
Brentford (City/Town), London (Greater)
Salary
£Competitive
Posted
08 Nov 2021
Closes
29 Nov 2021
Ref
307261
Contract Type
Permanent

Otilimab is a fully human monoclonal antibody that inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a protein that plays a central role in a broad range of immune-mediated diseases, including rheumatoid arthritis. GM-CSF acts on cells, including macrophages (an immune cell type that plays a key role in the inflammatory process), leading to inflammation, joint damage and pain. Otilimab neutralises the biological function of GM-CSF by blocking the interaction of GM-CSF with its cell surface receptor.

GSK is currently conducting a phase 3 development program studying otilimab in rheumatoid arthritis and planning other LCM opportunities.

Purpose of the role:

The GMAL role is a unique opportunity for an experienced, innovative and motivated Medical Affairs leader to provide strategic medical affairs leadership for Otilimab – LCM indications.  The successful applicant will be accountable to the Vice President Global Medical Affairs Otilimab and COVID therapeutics to develop and execute the Medical Affairs strategy for Otilmiab LCM and provide scientific and medical information to leading decision makers and healthcare professionals in the key TA countries.

The Global Medical Affairs Leader is accountable for Phase IIIb/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 asset and be accountable for developing and delivering the Integrated Evidence Generation Plan (spanning late stage development and post launch market access support.).

Key responsibilities:

  • Gathering medical insights from the key external stakeholders to inform and shape product strategy.
  • Working closely with Vice President Global Medical Affairs Otilimab and COVID Therapeutics, MDL, commercial leader and others to optimize plans in support of a file, launch optimisation and life cycle strategy (integrated evidence plans)
  • Accountable for the execution of phase IIIb/IV studies, including post-approval commitments, if applicable.
  • Accountable for execution of the medical plan for the asset throughout its lifecycle
  • Developing and implementing scientific platform for asset and formulating the scientific communication strategy
  • Leading the global scientific engagement strategy for the asset, including at scientific congresses, advisory boards or other company organised events where appropriate.
  • Developing strong relationships with multiple external stakeholders.
  • Strong analytical mind-set and ability to quickly assess large amounts of information and distil into key messages and actions.
  • Providing opinion based on deep knowledge of emerging external environment, with clear focus on patients and unmet medical need
  • Accountability for the medical ABPI certification of launch materials and activities to ensure they are compliant with GSK SOPs and external industry standards.

Application of Knowledge

  • Leading and Embedding Medical Governance.
  • Formulating strategies for assets and develops evidence plans (in partnership with R&D).
  • Seeking relevant scientific / medical insight from stakeholder groups

Problem Solving & Innovation

  • Identifying gaps and opportunities based on emerging data, competitor activity
  • 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, payers, patient groups, learned societies, consortia and opinion leaders).
  • Expert knowledge of current and emerging treatment management issues, treatment evolution, guidelines, and health policies
  • Expertise in scientific issues related to clinical development, study design, data interpretation, study conclusions
  • 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.

Basic qualifications

  • MD with significant experience in immuno-inflammation.
  • Experience engaging and delivering having the LOC perspective as central for execution.
  • Mixed experience of strategic and operational track record in Medical Affairs.
  • Experience in execution at country and ‘above country’ Medical Affairs Leadership roles.
  • Successful track record in Global Roles, specifics of Medical Affairs and Late Phase Development.
  • Experience in drug development (Research & Development) and understanding of GCP regulatory and market access reimbursement requirements.
  • Excellent presentation, influencing and media skills for both internal and external audiences. 
  • Experience in the interaction and exchange of scientific information (in adherence with GSK scientific engagement principles)
  • Strong communication & collaborative team working skills, as the role involves interface with a wide range of stakeholders internally and externally
  • Rheumatologist preferred

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers.  As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.  Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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