Study Physician- Neuroinflammation, Immunology Cell Therapy

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 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 clinical development experience in Immunology/neroinflammation 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 Study Physician 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 Study Physician in Immunology Cell Therapy Neuroinflammation 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. As the Study Physician they are responsible for contributing to CART programs beginning in multiple sclerosis and moving to other immune mediated diseases. This is an excellent opportunity for an experienced and motivated drug developer to lead an innovative clinical stage cell therapy study. 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. The successful candidate will thrive in a fastpaced proactive cando culture be a highly effective internal and external team player as well as a strong communicator and collaborator.

Responsibilities:

Provide expert medical and scientific input to cell therapy clinical stage assets in development for multiple sclerosis and additional immunemediated diseases.

• Clinical authority representative for the study team Responsible for the design delivery and interpretation of clinical studies from phase 1 through pivotal ensuring compliance with GCP.

• Lead ongoing review and monitoring of clinical data to ensure quality data integrity investigation of data trends and safety including SAE/SUSAR/protocol deviations and periodic review of emerging safety efficacy and PK and biomarker data internally and by SRC/DMCs.

• Support the clinical development strategy from early target identification through late phase (with senior support as necessary) and secure crossfunctional alignment across wider AZ organization.

• Provide clinical development /disease expertise to research clinical pharmacology translational medicine regulatory biostatistics safety cell therapy delivery team (including CMC) and commercial colleagues as part of a cross functional team.

• Closely follow medical developments within the cell therapy immune mediated diseases and disseminate information within Clinical Development and the wider organization to transform trends and emerging data into innovative clinical plans.

• Support Immunology Cell Therapy Clinical Development at internal governance interactions and with external partners (as aligned with senior manager) including Investigators key external authorities and patient advocacy groups (e.g. regulatory site CROs and KEEs).

• Contribute to regulatory communication and preparation of clinical sections of study and program level documents (e.g. protocols ICFs IB briefing books BTD PIPs SAPs safety periodic reports).

• Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.

• May provide clinical strategic feedback to inlicensing opportunities.

Essential Skills/Experience:

• An MD or other equivalent degree from an accredited university or an MD or equivalent degree plus a PhD with specialty or experience in the immunology therapeutic area ideally with cell therapy expertise.

• Postgraduate subspecialty training medical training/board certification in relevant field with a history of holding substantive clinical positions at attending/consultant level preferably at a major academic medical center

• Minimum of 3 or more of expertise & experience in both the clinical setting and the drug development process specifically in designing clinical trials coupled with the appropriate regulatory insights.

• Experience as clinical trialist in Neuroinflammation ideally in Multiple Sclerosis with deep knowledge of the of the landscape especially in the United States with a proven ability to engage with key sites external experts and patient partners

• 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

• Significant experience in early and/or late phase clinical development including handson experience in the design delivery and interpretation of multiple clinical studies.

• Significant experience in the authoring of relevant regulatory documents including IND protocols ICF IB PIP briefing books as well authoring responses to HA / EC.

• Thorough understanding of the full drug development process including interpretation of nonclinical data and clinical study design and execution.

• Thorough understanding of clinical research methodology and biostatistics principles to facilitate innovative and efficient clinical trial design and clinical development plans with datadriven decisions.

• Knowledge of FDA EMA MHRA and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies in the United States Europe and rest of world.

• Attention to detail aim to generate highquality work and sense of passion and urgency to achieve team and program goals.

• Proven experience leading complex projects and working collaboratively with multiple team members regarding new strategies to ensure consistent communication.

• Demonstrated track record in delivering results.

• Proven ability to learn new information rapidly and effectively

Desirable Skills/Experience

• Experience of clinical/commercial interface

• Global external awareness within the therapeutic area and global regulatory environment

• Ability to travel nationally and internationally

At AstraZeneca we are dedicated to being a Great Place to Work where you are empowered to push the boundaries of science and fuel your ambitious spirit. There is no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration we are always committed to lifelong learning growth and development.

The annual base salary for this position ranges from $241613 to $362420. However base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Date Posted

Closing Date