Executive Director and US Medical Lead, Oncology Pipeline
GSKAbout the role
Are 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 la
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