Associate Director Clinical Scientist, Immunology Cell Therapy

AstraZeneca•Cambridge, MA

2d•$142,171 - $213,257•Onsite

About The Position

AstraZeneca is seeking an Associate Director Clinical Scientist, Immunology Cell Therapy to join their dynamic team in Cambridge, MA. This role is crucial for driving the strategy and execution of early-phase clinical development for cell therapy programs targeting immune-mediated diseases. The position involves close collaboration with cross-functional teams, including Oncology and Alexion, and acting as a liaison between the Global Project Team (GPT) and externally sponsored collaborative research. The Associate Director will ensure compliance with GCP, AstraZeneca quality systems, and regulatory guidelines, while integrating scientific knowledge with clinical strategy to deliver impactful cell therapies to patients.

Requirements

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

Nice To Haves

Expert level knowledge of cell therapy for immune-mediated diseases is preferred, especially rheumatology or related indications.
Line management experience is advantageous.
Experience supporting delivery and influencing at senior leadership levels internally and externally.
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.

Responsibilities

Support the clinical program strategy and clinical science delivery for early-phase, immunology cell therapy programs.
Integrate knowledge of biology, translational hypotheses, and biomarkers with clinical science.
Plan, direct, and deliver the clinical science components of assigned clinical programs from design concept to final CSR.
Provide medical and 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.
Support clinical input to the Clinical Development Plan (CDP).
Prepare clinical and other data for governance and senior leadership presentations.
Contribute to recommendations to internal committees.
Support preparation and maintenance of program-level documents such as the Investigator’s Brochure (IB) and DSUR.
Monitor and synthesize developments in the scientific/medical literature and communicate implications to the team.
Ensure scientific input to therapy-area standard.
Collaborate with Lead Bio scientists and Translational Scientists to provide clinical input to pre-CDID cell therapy products.
Support the development, review, and quality of publications and publication strategy.
Serve as the clinical science resource for assigned studies (and in some instances as the Study Clinical Lead).
Support/lead development of Clinical Study Protocols (CSPs), informed consent forms (ICFs), and electronic data capture (EDC) database specifications.
Support ongoing clinical data review and interpretation at study and program level.
Contribute to development of quality metrics and data review plans for assigned studies.
Support and contribute to medical monitoring of trials.
Support the compilation and interpretation of data for dose-escalation/safety review committees.
Support protocol amendments and other strategic documents.
Support review of the Clinical Study Report.
Co-lead/support ESCR strategy and implementation for the program.
Serve as the interface between the GPT and external clinical research.
Support investigator/site relationships for site selection and study start-up.
Co-lead/support clinical proposal reviews, protocol reviews, and scientific oversight for academic basket/umbrella and ESCR studies.
Identify and manage ESCR portfolio risks and escalate quality issues through appropriate channels.
Support representation of the project internally and externally with key experts and partners and contribute to alliance development.