ESSENTIAL SKILLS/EXPERIENCE:

• Ph.D. MPhil or Pharm D., with 3 – 5 years of clinical study and clinical development experience.
• 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:

• 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 integrates multiple perspectives into the clinical development process for best end-results.
• 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 bold 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 individual flexibility. Join us in our unique and daring world.

LOCATION: OFFICE BASED ROLE IN BOSTON SEAPORT MA, USA

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 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 an Associate Director Clinical Scientist, Immunology Cell Therapy to be based in Boston Seaport.

WHAT YOU’LL DO

The Associate 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 AstraZeneca’s global objectives and the value targets of our portfolio. As the Associate Director Clinical Scientist, 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 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.