Executive Director and US Medical Lead, Oncology Pipeline - Durham North Carolina

Company: GlaxoSmithKline
Location: Durham, North Carolina
Posted On: 01/22/2025

Site Name: USA - Pennsylvania - Philadelphia, USA - North Carolina - DurhamPosted Date: Jan 16 2025Are you looking for a leadership opportunity to drive growth and continuous improvement in Oncology medical affairs? If so, this role may be for you!The US Medical Affairs Lead Oncology Pipeline role is focused on providing US medical leadership, input and support for key emerging assets in development, ensuring US Market needs/insights are considered and integrated into product development, evidence generation, and launch plans. This role will also work with the US Oncology Therapeutic Head to ensure the US Medical team has the appropriate expertise and resources in place to support new medicines coming to market. They will partner closely with Commercial Early Asset leads, Global Medical Affairs, and R&D teams.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Key Responsibilities:

• Maintains understanding of US market dynamics and treatment landscape associated with priority pipeline assets in the Oncology research units.
• Serves as the US representative on pipeline Global Medical Affairs teams and co-creates medicine strategy and plans; Represents US Medical Affairs across matrix teams to ensure high quality medical plans are established.
• Gathers and communicates medical insights from internal and external stakeholders (Investigators/HCP's, Patients, Payors and Regulators) to shape product development decisions, Global Medical Affairs Plans, and integrated evidence strategy and plan.
• Develops pipeline medical affairs plans and operational model laying the initial foundation for future Medical Affairs launches; Performs advanced scenario-planning and preliminary preparation for US launches.
• Inputs into the design of Clinical Trials, development plans, and Integrated Evidence planning; coordinating with relevant Global Medical Team roles and R&D technical experts e.g. Global Value Evidence and Outcomes and Epidemiology as required.
• Understands and communicates clinical and market access data requirements for US market; shapes clinical and health outcomes evidence plans to support anticipated US Market needs.
• Partners with Global Medical Affairs on Advisory Board design and discussion, ensuring compliance with SE governance and documentation requirements.
• Leads US Medical/Clinical Operations partnership process, determining scope of US Medical Affairs support for ongoing US Clinical Trials.
• In partnership with US Medical Affairs Lead and US Head, ensures early input into priority US research site strategy (COEs, Cooperative groups, Research Networks) and key US external stakeholders; builds external relationships in partnership with Field Medical and collaborates with internal R&D stakeholders to foster internal relationships with external experts & leaders.
• Facilitates preparation of US Therapeutic Area Head for GSK Product Investment Board review/ Brand Planning processes, ensuring compliance with timelines and mandated global templates; updates Field Medical Teams and other internal stakeholders on pipeline progress and status.
• Serves as Medical point for US input into Business Development and Acquisition opportunities.
• In partnership with US Medical Communications and Scientific Training team, shapes, reviews, and approves Globally created Scientific Communication and Medical Information materials that will be used with US HCPs, ensuring alignment with US medical strategy and business needs.
• Drives cross-functional influence and collaboration internally across divisions.
• Leads a team of Medical Directors in support of the Oncology pipeline, prioritizing resources and efforts against highest priority programs.
• Accountable for budget management to plan.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
  • PharmD, PhD, MD- Medical Doctor- Board Certification (or equivalent credentials).
  • Experience launching Oncology products in the US.
  • 5-10 years Medical Affairs or Clinical Development experience.
  • Experience in one or more of the following tumor areas: Lung, Head and Neck, Sarcoma, CRC.
  • Experience influencing and informing clinical development plans for US commercialization success.
  • Experience leading and managing cross-functional work.
  • Drug development (early through late stage) experience with knowledge of GCP regulatory/ market access and reimbursement requirements.
  • US Medical Affairs and life cycle management, including launch support requirements.
  • Significant diverse disease and therapeutic area experience.
  • Robust knowledge base of promotional codes/ regulations; previous involvement in review and approval processes.Preferred Qualifications:If you have the following characteristics, it would be a plus:
    • Demonstrated ability to build strong internal and external networks.
    • Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.#LI-GSKPlease visit to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.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/ AgenciesGSK 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 site.
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