Scientific Director - Early Assets
Are you interested in a highly visible medical affairs role that allows you to design training and program content that educates and shapes awareness of our medicines? If so, this Medical Affairs Scientific Director role could be an ideal opportunity to explore.
A Medical Affairs Scientific Director has a strong clinical and scientific training and is capable of taking on many aspects of medical affairs activities (clinical and economic evidence generation, external and scientific engagement, provision of medical advice to internal stakeholders). The Early Assets Scientific Director role is focused on providing US medical leadership and support for key Oncology assets in development, ensuring US Market needs are considered and integrated into product development plans. This role will also work with the US Oncology Therapeutic Head to ensure the US Oncology Medical team has the appropriate expertise and resources in place to support new medicines coming to market. They will partner closely with Oncology Global Franchise 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
- Gathers medical insights from internal and external stakeholders (HCP’s, Patients, Payors and Regulators) to shape the integrated evidence strategy and plan.
- Leads Advisory Board design and discussion, ensuring compliance with SE governance and documentation requirements (Approval Templates; GLASSES etc).
- Develops US LCM plan for Life-Cycle Management (LCM) assigned compounds.
- Inputs to the design and delivery of phase 2 trials, to generate data needed for signal generation, data gaps and LCM, coordinating with relevant Global Medical Team roles and R&D technical experts e.g. Global Health Organization and Epidemiology as required.
- Facilitates preparation for the aPIB review/ Brand Planning processes, ensuring compliance with timelines and mandated global templates to ensure consistency across Franchises/ Franchise LOCs.
- Plays an integral role in the development and approval of Scientific Communication materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc).
- Communicating effectively the clinical and market access data for their asset to key US Stakeholders; ensures a robust understanding of risk: benefit.
- Responsible for providing significant input into the Medical Affairs strategy and IEP for assigned assets; Responsible for driving excellence in external engagement - building credibility with, and insights through, a strong external network.
- Building credibility through the richness of his/her content expertise.
- Responsible for the successful delivery of Medical Affairs plans in accordance with GSK and statutory requirements.
We are looking for professionals with these required skills to achieve our goals:
- PharmD, PhD or equivalent (minimum qualification)
- Industry and/or clinical experience in the oncology therapeutic area
- Broad drug development experience with robust knowledge of GCP regulatory/ market access and reimbursement requirements.
- Significant experience in Medical Affairs and life cycle management preferred, including launch support requirements.
- Significant disease and therapeutic area knowledge.
- Robust understanding of promotional codes/ regulations; previous involvement in review and approval processes.
- Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
- Demonstrated ability to build strong internal and external networks
If you have the following characteristics, it would be a plus:
- Medical Doctor- Board Certification (or equivalent credentials) in Oncology (preferred qualification)
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