Study Physician - Immunology Cell Therapy

Study Physician – 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 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 a Study Physician - 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 world class organization that accelerates the delivery of transformative cell therapies for patients with immune mediated diseases. It’s 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 cutting-edge 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 Study Physician in Immunology Cell Therapy 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 including the development of CAR-T cell therapies for autoimmune or inflammatory diseases. This is an excellent opportunity for an experienced and motivated drug developer to lead an innovative clinical stage cell therapy study.

The Study Physician will provide medical and scientific input to T-cell therapy clinical stage assets focused on rheumatology or clinical immunology. They will take ownership for clinical development in cross-functional teams to support early to late phase clinical development activities. These include the creation of overall clinical development plans and clinical study design, writing study concepts and protocols, key study and health authority documentation, medical monitoring and ensuring timely delivery of studies, all in close collaboration with relevant internal and external partners and clinical research organizations.

Experience in early and/or late-stage cell therapy drug development is highly desired, and preferably with rheumatology drug development experience (including diseases such as systemic lupus erythematosus, myositis, scleroderma, and other inflammatory diseases). The successful candidate will thrive in a fast-paced, proactive can-do culture, be a highly effective internal and external team player as well as a strong communicator and collaborator.

Responsibilities:

• 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 cross-functional 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 autoimmune / inflammatory 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 in-licensing opportunities.

Essential Skills/Experience:

• An MD, or other equivalent degree from an accredited university or an MD or equivalent degree plus a PhD.

• 3 or more years of validated experience in clinical development.

• Experience in clinical development of T-cell therapy is helpful.

• Experience in rheumatology/clinical immunity is preferred.

• Significant experience in early and/or late phase clinical development, including hands-on 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 non-clinical 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 data-driven 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 high-quality 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.

• Outstanding verbal and written communication skills.

• Excellent analytical, problem solving and strategic planning skills.

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 $241,613 to $362,420. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term 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 “at-will 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. 

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 authorisation and employment eligibility verification requirements.