Global Medical Affairs Leader/Sr. GMAL
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Global Medical Affairs Leader/Senior Global Medical Affairs Leader in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
The Sr. GMAL/GMAL IO will provide cross functional medical leadership for the GU cancer indications within the Global Medical Affairs Team in charge of AstraZeneca late stage IO drugs (Durvalumab & tremelimumab), and lead the medical strategy and execution of key deliverables to support the IO launch and lifecycle management globally. This Sr GMAL role reports to the IO VP lead in the GMA team.
The core accountabilities of this role are to:
- Provide a coordinated approach to building AstraZeneca’s medical leadership in IO, and deliver medical insight into the development and execution of an overall IO GU disease area strategy.
- Oversee and support the development and execution of the asset specific integrated medical plans (evidence generation and scientific communications), including global external experts, diagnostics and patient centric activities.
- Partner closely with colleagues in the Markets, Development, early Oncology Research & Development, Regulatory, Commercial, Access, Health Outcomes and other key functions, and help build alignment on key initiatives including optimal approach to data generation, communication and supporting access.
- Participate (or lead upon delegation by the IO VP lead) the GMT (Global Medical Team) and manage appropriate involvement of prioritized market teams to ensure that market insights are used to inform product development and Global deliverables
- To interface with internal and external stakeholders to enhance the scientific and clinical understanding of the drugs
- To act as Medical Study lead for ongoing studies, being responsible for:
- Patient safety monitoring throughout the study
- Dissemination of relevant Durvalumab & Tremelimumab emerging safety information
- Core Team updated with relevant safety information
- Co-sharing with MEOR Oncology Director STRONG Core Study Team
- Coordinating with Study Statistician the Data Monitoring Committee (DMC) meetings and activities
- Coordinating Steering Committee meetings and activities
- Coordinating with other therapeutic area IO MALs the input to the development of protocol design, modules, amendments, ICFs for any study module
- Coordinating study material reviews and input to study related communications
- Providing medical support to HA and IRB regulatory interactions and to CRO in charge of study execution
- Advanced scientific degree (M.D or PhD) with hematology/oncology experience (required)
- Medical Affairs experience (3+ yr) is required, preferably with country launch experience. At least 4+ years total or pharmaceutical or relevant medical/clinical experience minimum
- Understanding of drug development and commercialization processes including understanding of outcomes research /payor access issues.
- Proven ability to generate, analyze and interpret clinical trial and published data
- Track record of successfully developing and executing Medical Plans both in terms of evidence generation, scientific communications and external expert engagements.
- Ability to manage multiple projects and products simultaneously to ensure timely, on-target and within budget accomplishment of tasks.
- The candidate is expected to have strong project management skills and ability to work effectively with cross functional teams including development, marketing, and health outcomes.
- Good communication and presentation skills in English
Next Steps – Apply today!
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.