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Global Development Scientist Associate Director - Boston Massachusetts
Company: AstraZeneca GmbH
Location: Boston, Massachusetts
Posted On: 05/02/2025
Location: Office based role in Boston Seaport MA, USAAre you a visionary expert in clinical drug development, possessing the capabilities to drive a successful strategy in accelerating the development of cellular therapies for patients with immune-mediated diseases? Are you dedicated to revolutionizing the treatment of immune-mediated diseases and creating a significant impact on patients' lives? Do you have a strong passion for science and substantial clinical development experience in Immunology and CAR-T cell therapies? Do you possess both strategic and operational leadership skills? If so, we invite you to join us! We are currently seeking a Global Development Scientist Associate Director, Immunology Cell Therapy to be based in Boston Seaport.About AstraZenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. We are more than one of the world's leading pharmaceutical companies.Immunology Cell TherapyOur ambition is to build a world class organization that accelerates the delivery of transformative cell therapies for patients with immune mediated diseases. It's our big vision that unites and inspires us. Cell therapies represent a fundamental evolution of how drugs are discovered, developed and manufactured, these new advanced potentially curative cellular modalities require a new development strategy to ensure their rapid availability to patients. With multiple autoimmune and inflammatory indications and clinical stage cell therapies in global development, we keep pushing forward. Focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes.What You'll DoThe Global Development Scientist Associate Director holds an expert position within the new and dynamic immunology cell therapy organization at AstraZeneca. This is an exceptionally exciting and prestigious role, contributing significantly to AstraZeneca's global objectives and the value targets of our portfolio. As the Global Development Scientist Associate Director, you are responsible for spearheading clinical science for immunology cell therapy across immune mediated diseases programs. Moreover, this role offers the unique opportunity to collaborate closely with cross-functional teams at the enterprise level, including Oncology, Alexion, and several development partners, thereby enhancing the overall impact and reach of the position.Responsibilities: In collaboration with the Global Clinical program leads, you will be accountable for the clinical program strategy, including innovative approaches to delivery, e.g., new delivery platforms and technology to ensure patient engagement, recruitment and retention. You will be in charge of planning, directing and delivering the operational components of assigned clinical programs from design concept to final CSR. The accountabilities are broad; however, the core accountabilities are the medical & scientific support for the development and implementation immunology cell therapy sponsored clinical program strategy, externally sponsored collaborative research program strategy and studies, including clinical science support for initiating clinical trial(s). You will lead a team of clinical scientists that provide expert scientific input crucial in the preparation of regulatory documents and interactions with regulatory authorities. You will also lead development of quality metrics and data review plan for assigned studies, support and contribute to medical monitoring of trials, and ensure scientific input to TA standards.Essential Skills/Experience: - Ph.D. MPhil or Pharm D., with 3 - 5 years of industry experience in clinical development.
- Expert level knowledge of the therapeutic area (i.e., cell therapy, preferably in rheumatology or other immune mediated diseases).
- Experience designing and driving industry-sponsored clinical trials.
- Significant experience in the authoring of relevant regulatory documents.
- Detailed understanding of the full drug development process.
- Adaptive problem solving and learning and ability to navigate complex organizations and systems.
- Ability to influence both high level internal and external stakeholders.
- Ability to frame clear & succinct messages and simplify complexity of decision making.
- Track record of leading successful high performing global cross-functional team as well as line management experience.
- Global external awareness within the therapeutic area and global regulatory environment.
- Expert level knowledge of the principles of clinical trial methodology, statistics, data analysis and interpretation.
- Experience leading the development and implementation of cell therapy studies, including protocol and ICF development, electronic data capture database development, safety assessment, IB/DSUR submissions, and clinical data review. Authority in scientific literature searches and weighing of quality peer reviewed data.
- Experience leading varying levels of internal/external management, Investigators and site personnel, clinicians, scientists, and cross-functional teams.Desirable Skills/Experience:
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