Oncology Global Medical Affairs Leader, Synthetic Lethality

Glaxosmithkline Philadelphia , PA 19107

Posted 2 months ago

Site Name: USA

  • Pennsylvania

  • Philadelphia, USA

  • Pennsylvania

  • Upper Providence

Posted Date: Jan 20 2020

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 Zejula 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, PhD or PharmD qualified with strong experience in oncology and specifically synthetic lethality.

  • Proven Global Medical Affairs leadership experience in country and above country roles.

  • Experience with Pre-Launch activities.

  • Oncology drug development experience.

  • 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.

Preferred: Board certified oncologist

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/Affirmative Action Employer. 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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Oncology Global Medical Affairs Leader, Synthetic Lethality

Glaxosmithkline