Senior Director Clinical Scientist
Senior Director Clinical Scientist
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1 Vacancy
Job Description
Are 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 immunemediated diseases Are you dedicated to revolutionizing the treatment of immunemediated 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 CART cell therapies Do you possess both strategic and operational leadership skills If so we invite you to join us! We are currently seeking a Senior Director Clinical Scientist Immunology Cell Therapy to be based in Boston Seaport.
About AstraZeneca
AstraZeneca is a global scienceled patientfocused biopharmaceutical company that focuses on the discovery development and commercialization of prescription medicines for some of the worlds most serious diseases. We are more than one of the worlds leading pharmaceutical companies.
Immunology Cell Therapy
Our ambition is to build a world class organization that accelerates the delivery of transformative cell therapies for patients with immune mediated diseases. Its 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 cuttingedge 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 Youll Do
The Senior Director Clinical Scientist 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 AstraZenecas global objectives and the value targets of our portfolio. Reporting directly to the Head of Immunology Cell Therapy in Boston will also be a pivotal member of the leadership and clinical teams working in an adaptive matrixed environment. As the Senior Director Clinical Scientist. they are responsible for spearheading clinical science for immunology cell therapy across immune mediated diseases programs. The Senior Director Clinical Scientist is the most senior clinical science expert in immunology cell therapy and will lead a team of expert clinical scientists across the portfolio. Moreover this role offers the unique opportunity to collaborate closely with crossfunctional 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 with lead a team of clinical scientists that provide expert scientific input will be 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 10 plus 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 industrysponsored 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 crossfunctional 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 crossfunctional teams.
Desirable Skills/Experience:
- Comprehensive knowledge of the multidisciplinary functions involved in a companys cell therapy development process e.g. research clinical operations clinical pharmacology translational medicine biostatistics regulatory safety CMC commercial operations.
- Experience proactively integrates multiple perspectives into the clinical development process for best endresults.
- Experience in clinical development of CARTcell therapy is highly desired.
- Global external awareness within the therapeutic area and global regulatory environment.
- Ability to travel nationally and internationally.
When we put unexpected teams in the same room we fuel bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.
Why AstraZeneca
At AstraZeneca we are driven by following the science. We are a sciencedriven organization where innovation is backed by investment and bold decisionmaking. Here your innovative discoveries will ultimately have the potential to reach billions of patients in need all across the globe. We are a team of leading specialists driven to pursue scientific knowledge. We see the bigger picture and know where we can make the biggest impact. We are never complacent about scientific discovery and development. Here we are always pushing our efficiency searching for new knowledge and the next breakthrough.
Ready to make a greater impact Apply now!
Date Posted
07Apr2025Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Exec
Employment Type
Full-Time
