Clinical Research & Development Associate Director Myositis/Immunology

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 Kendall Square in Cambridge, MA.

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.

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.

The Associate Director Clinical Scientist holds an expert position within the new and dynamic Immunology Cell Therapy organization at AstraZeneca and is a key member of the Global Project Team (GPT). Working under the supervision of a Clinical Lead/Study Physician or Senior Clinical Scientist, you will support—and over time increasingly lead—the medical and scientific aspects of early-phase clinical development for cell therapy programs across immune-mediated diseases. This is an exceptionally exciting and prestigious role, contributing significantly to AstraZeneca's global objectives and the value targets of our portfolio. You will partner closely with cross-functional teams at the enterprise level, including Oncology, Alexion, and several development partners, and act as the link between the GPT and externally sponsored collaborative research for your program. You will operate in compliance with GCP, AstraZeneca quality systems and relevant regulatory guidelines.

In collaboration with the clinical program leads you will be accountable for the clinical program strategy and clinical science delivery for early-phase, immunology cell therapy programs, including innovative approaches to delivery (e.g., new digital platforms and technology to ensure patient engagement, recruitment and retention). You will integrate knowledge of biology, translational hypotheses and biomarkers with clinical science, and you will plan, direct and deliver the clinical science 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 of immunology cell therapy sponsored clinical program strategy and externally sponsored collaborative research (ESCR) program strategy and studies, including:

• Program level: Supporting clinical input to the Clinical Development Plan (CDP); preparing clinical and other data for governance and senior leadership presentations; contributing to recommendations to internal committees; supporting preparation and maintenance of program-level documents such as the Investigator’s Brochure (IB) and DSUR; monitoring and synthesizing developments in the scientific/medical literature and communicating implications to the team; ensuring scientific input to therapy‑area standard; collaborating with Lead Bio scientists and Translational Scientists to provide clinical input to pre‑CDID cell therapy products; supporting the development, review and quality of publications and publication strategy.

• Study level: Serving as the clinical science resource for assigned studies (and in some instances as the Study Clinical Lead); supporting/leading development of Clinical Study Protocols (CSPs), informed consent forms (ICFs), and electronic data capture (EDC) database specifications in line with the approved CDP and target product profile; supporting ongoing clinical data review and interpretation at study and program level with input from the study/program physician; contributing to development of quality metrics and data review plans for assigned studies; support and contribute to medical monitoring of trials;  supporting the compilation and interpretation of data for dose‑escalation/safety review committees; supporting protocol amendments and other strategic documents; and supporting review of the Clinical Study Report.

• ESCR and external engagement: Co‑leading/supporting ESCR strategy and implementation for the program; serving as the interface between the GPT and external clinical research; supporting investigator/site relationships for site selection and study start‑up; co‑leading/supporting clinical proposal reviews, protocol reviews and scientific oversight for academic basket/umbrella and ESCR studies; identifying and managing ESCR portfolio risks and escalating quality issues through appropriate channels; supporting representation of the project internally and externally with key experts and partners and contributing to alliance development.

Essential Skills/Experience:

• Advanced degrees Ph.D., MPhil or PharmD with 0–5 years of industry clinical development experience.

• Basic knowledge of clinical practice across immune‑mediated disease indications with the ability to rapidly acquire knowledge; expert level knowledge of cell therapy for immune‑mediated diseases is preferred, especially rheumatology or related indications.

• Understanding of T‑cell biology and gene therapy, with experience in the clinical development of engineered cell therapies (CAR‑T highly desired).

• Experience designing and driving industry‑sponsored clinical trials, including protocol and ICF development, EDC database specifications, safety assessment, IB/DSUR submissions, and clinical data review; significant experience authoring relevant regulatory documents and participating in regulatory interactions.

• Detailed understanding of the full drug development process and expert knowledge of clinical trial methodology, statistics, data analysis and interpretation.

• Experience working and leading in matrix teams; ability to influence both high‑level internal and external stakeholders; strong collaborative communication skills with the ability to engage a diverse internal and external client base and manage through conflict.

• Adaptive problem solving and learning agility; ability to navigate complex organizations and systems; proven ability in problem solving and issues management that is solution‑focused.

• Track record of leading successful high‑performing global cross‑functional teams; line management experience is advantageous. Experience supporting delivery and influencing at senior leadership levels internally and externally.

• Global external awareness within the therapeutic area and global regulatory environment; credibility with investigators, academic partners, consortia and CROs.

Desirable Skills/Experience:

• Advanced degrees Ph.D., MPhil or PharmD with 2 plus years relevant clinical drug development or medical research experience in a pharmaceutical or biotech environment. 

• Comprehensive knowledge of the multidisciplinary functions involved in cell therapy development (e.g., research, clinical operations, clinical pharmacology, translational medicine, biostatistics, regulatory, safety, CMC, commercial operations).

• Experience proactively integrating multiple perspectives—clinical, translational and operational—into development plans for best end‑results.

• Experience in clinical development of CAR‑T‑cell therapy is highly desired.

• Experience with Sjogren’s Disease, inflammatory myositis or juvenile idiopathic arthritis is highly desired

• Ability to travel nationally and internationally.

The annual base pay (or hourly rate of compensation) for this position ranges from $142,171.20 - $213,256.80 USD Annual Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.