VP Immuno-Inflammation Early Assets & Global Health

Glaxosmithkline Collegeville , PA 19426

Posted 3 weeks ago

Site Name: UK - London

  • Brentford, USA - Pennsylvania

  • Upper Providence

Posted Date: Feb 6 2020

Position Summary

The VP, Immunology Early Assets & Global Health is a new role in the GSK Global Medical Affairs organisation. You will have the opportunity to provide strong and impactful medical leadership to the early assets in Immuno-Inflammation, Hepatology and Global Health. The VP, Immunology Early Assets & Global Health will provide medical leadership, disease area expertise and patient and prescriber insights at the portfolio, as well as provide medical insights into proposed new areas of interest, assets in development and portfolio strategy and prioritisation.

This new role will interact primarily with the Immunology & Fibrosis and Respiratory & Specialty Clinical Science SVPs within the Development organisation, and partner with the VP Pipeline & Portfolio Strategy in the Commercial organisation to shape early asset plans and provides medical insights into governance activities. You will ensure active collaboration on Development projects (from Phase II onwards) and business development/due diligence activities. A team of global medical directors will report directly to the new VP, and you will develop and maintain medical excellence through talent identification, recruitment, development and retention, especially of physicians to support the pipeline.

You will be a key member of Specialty & Primary Care, Classic and Established Products Medical Leadership Team and other teams in connection with the Development and Commercial organisations.

You will have significant business accountability as the new VP is responsible for assuring appropriate medical expertise to support the late stage portfolio, a critical determinant when assessing pipeline valuation. As a result, you will have influence starting in early development through commercialisation of assets in the portfolio.

The role reports to Marco Avila, VP Specialty & Primary Care, Classic and Established Products Global Medical.

Location of the role

Upper Providence, Pennsylvania, US or GSK House, London, UK.

Key Responsibilities

  • Accountable for providing the senior medical and scientific input into the Development Review Board, Medicines Development Teams, and Global and Regional Commercial functions in support of the early Development Pipeline (the Global Medical Affairs Leader remains the key player within MDTs from a Medical Perspective).

  • Provides insights to SVPs, Heads Clinical Sciences and Clinical Development/Scientific points of contact for portfolio leadership for the MDTs.

  • Provides medical perspective and insights in the Early Development process.

  • Provides leadership to ensure accuracy, quality and timeliness of Clinical Development Plans, clinical life cycle management activities and clinical components of required regulatory submissions, throughout the life cycle, working with the Clinical Scientist accountable at the asset/marketed product level.

  • Provides advice and guidance on specific clinical development, marketed product management and safety/efficacy issues and/or strategy within a project.

  • Provides leadership for all the above leveraging relationships with other senior leaders across R&D and their partner organisations.

  • Accountable for the accuracy and scientific integrity of Medical input to Regulatory documents with global impact supporting the asset level PPLs for the pipeline assets within their portfolio.

  • Accountable for global, regional or local Medical Affairs governance of the early pipeline working with the accountable Clinical Science stakeholders to ensure proper integration with Development and priority LOCs.

  • Accountable for the creation of integrated Medical Affairs Plan for the asset supporting each GMAL or Medical personnel assigned.

  • Accountable for the management and allocation of Medical personnel across projects and programs within their portfolio and ensure staff within their organization deliver on their accountabilities across the portfolio.

  • Accesses world-class expertise through external collaboration and strategic consultancies.

  • Ensures appropriate resourcing across the portfolio, aligned with prioritisation:

  • Lead project oversight to ensure timely, efficient and compliant delivery of Medical activities according to GSK metrics and policies

Candidate Profile

Experience and Qualifications required:

  • Medical Doctor and PhD preferred

  • Clinical Development Expertise

  • Demonstrates an understanding of the required steps to progress a new chemical lead through the stages necessary to allow it to be tested in human clinical trials. Has demonstrated experience in the design, development, execution, statistical analysis, clinical interpretation and reporting of high-quality clinical studies.

  • Good Clinical Practice Knowledge

  • Demonstrates the ability to ensure an investigation is conducted according to applicable Good Clinical Practice regulations and internal control documents, to protect the rights, safety and wellbeing of subjects and the accuracy and validity of the trial data.

  • Clinical Judgement Experience

  • Proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with appropriate SOPs, policies, guidance and codes.

  • Scientific and Medical Knowledge

  • Demonstrates a current, in-depth understanding of the relevant drug and associated therapeutic and disease area.

  • Clinical Data Stewardship

  • Demonstrates an understanding of the critical importance of rigorous data generation and disciplined stewardship of the data.

  • Medical Monitoring/Pharmacovigilance

  • Demonstrates an understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients. Knows when to involve GCSP for escalation e.g. to the Chief Medical Officer, Global Safety Board.

  • Reimbursement/Market Access Knowledge

  • Demonstrates a thorough understanding of the attributes of a medicine that are likely to be valued by payers, and the evidence required to support the payer value proposition. Understands the importance of designing and executing the trial to achieve future marketing authorisation.

  • Scientific Writing

  • Demonstrates the ability to produce scientific communications with clarity, accuracy and rigour and in compliance with GSK control documents governing disclosure, publication and principles of scientific exchange.

  • This is a highly visible, influential leadership role, requiring excellent networking, communication and influencing skills to work effectively in a highly matrixed environment

Core Competencies

  • Leadership capability - demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities.

  • Strategic Thinking - maintains competitive advantage by carefully considering the issues and competing priorities within a situation, program or portfolio and then developing a strategy that includes the strategic application of available principles, tools and systems.

  • Business Acumen

  • Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D.
  • Project Management
  • Demonstrates the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.

Compensation

Commensurate with the important responsibilities of this critical role, the successful candidate will be paid a competitive Total Rewards package including relocation support.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.


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VP Immuno-Inflammation Early Assets & Global Health

Glaxosmithkline