Senior Director Clinical Scientist

Are you an authority in 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 passion for science and meaningful 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 Senior Director Clinical Scientist, Immunology Cell Therapy to be based in Boston Seaport.

About AstraZeneca

AstraZeneca 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 Therapy

Our ambition is to build a premier organization that accelerates the delivery of transformative cell therapies for patients with immune mediated diseases, our big vision unites and encourages 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 ground breaking 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 Do

The Senior Director Clinical Scientist holds an authoritative position within the new and dynamic immunology cell therapy organization at AstraZeneca. This is an exciting and prestigious role, contributing significantly to AstraZeneca's global objectives and the value targets of our portfolio. Reporting directly to the Head of Immunology Cell Therapy in Boston, you will be a pivotal member of the leadership and clinical teams working in an adaptive matrixed environment. The Senior Director Clinical Scientist is responsible for spearheading clinical science for immunology cell therapy across immune mediated diseases programs. As the most senior Clinical Scientist in immunology cell therapy, you lead a team of clinical scientists across the portfolio. Moreover, this role offers the unique opportunity to collaborate closely with teams at the enterprise level, including Oncology, Alexion, and several development partners, thereby improving 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 ways to delivery, e.g., new delivery platforms and technology to ensure patient engagement, recruitment and retention. You will oversee planning, directing and delivering the operational components of assigned clinical programs from design concept to final CSR.

You are accountable for the medical & scientific support of studies, the development and implementation of 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 the 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 15 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 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 sophisticated organizations and systems
• Ability to influence both high level internal and external collaborators.
• Ability to frame clear & succinct messages and simplify complexity of decision making.
• Track record of leading high performing global cross-functional teams as well as line management experience.
• Global 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:

• Comprehensive knowledge of the multidisciplinary functions involved in a company’s cell therapy development process, e.g., research, clinical operations, clinical pharmacology, translational medicine, biostatistics, regulatory, safety, CMC, commercial operations.
• Experience proactively integrating multiple perspectives into the clinical development process for the best end-result.
• Experience in clinical development of CAR-T-cell 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 ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible., we balance the expectation of being in the office while respecting flexibility. Join us in our unique and daring world.

Why AstraZeneca?

At AstraZeneca, we are driven by 'following the science'. We are a science-driven organization where innovation is backed by investment and bold decision-making. 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!