Process Research Director jobs in Massachusetts

Are you ready to make a significant impact in the world of Biopharmaceuticals R&D? We are seeking a Director Clinical Scientist to join our team in Boston. This role will provide scientific and clinical input to all aspects of product development for Immunology Cell Therapy assets. You will have the opportunity to work on ground-breaking medicine discovery and development from early to late stage, answering some of the most complex unmet patient needs.

Accountabilities:

As a Director Clinical Scientist, you will provide scientific leadership in the innovative design, execution, and interpretation of clinical trials in one or more development programs. You will collaborate with colleagues in other functions including Study Physician, Patient Safety, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups. Your 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:

• Advanced scientific degree (M.S., Ph.D., Pharm D., MPH, or equivalent degree) with 3 plus years of industry experience in clinical development.
• Advanced knowledge of the therapeutic area (i.e., cell therapy, preferably in rheumatology or other inflammatory diseases).
• Experience designing and driving industry-sponsored clinical trials.
• Broad understanding of the principles of clinical trial methodology, statistics, data analysis and interpretation.
• Experience providing scientific support for 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.
• Ability to clearly communicate to internal and external partners orally and in writing.
• Experience interacting with varying levels of internal/external management, Investigators and site personnel, clinicians, scientists, and cross-functional teams.

Desirable Skills/Experience:

• In-depth 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.

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.

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!

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 authorization and employment eligibility verification requirements.