Clinical Scientist Director

AstraZeneca•Boston, MA

5d•Hybrid

About The Position

Are you ready to shape pivotal late-stage trials that redefine standards of care in immunology and directly impact patients worldwide? In this role, you will lead the scientific design, delivery and interpretation of decisive clinical studies that determine benefit, risk and value. Your work will power evidence-based decisions and accelerate medicines toward those who need them most. You will partner closely with the study physician and a cross-functional team to ensure trial integrity, exemplary data quality, and a seamless safety evaluation process. How will you use your expertise to turn complex data into clear action, guide regulatory strategy, and influence program direction from the first patient in to submission?

Requirements

Scientific doctoral level degree (e.g. PhD or PharmD), relevant equivalent clinical qualification, or other relevant university degree with extensive experience from clinical development.
Five or more years of relevant pharmaceutical industry experience (multi-country clinical trials) is required.
Understanding of scientific and clinical issues related to the design and implementation of clinical trials and interpreting trial results particularly in respiratory and immunology clinical development.
Proven ability to work collaboratively in a cross-functional setting.
Experience particularly in Phase II and Phase III clinical development.

Nice To Haves

Experience with regulatory submissions, life cycle management, advisory boards, annual safety updates.

Responsibilities

Lead innovative design of Phase IIb and Phase III trials to answer decisive scientific and clinical questions aligned to program strategy.
Provide clinical and scientific guidance across one or more programs, ensuring strong hypotheses, endpoints and evidence plans that stand up to scrutiny.
Define quality metrics and data review plans for assigned studies; monitor trends to safeguard integrity and extract actionable insights.
Orchestrate an end-to-end safety evaluation process for pivotal trials, partnering with Patient Safety and study physicians to anticipate, detect and manage risk.
Collaborate effectively with Clinical Operations, Biostatistics, Regulatory Affairs, Patient Safety, and early development teams to deliver trials across geographies at pace.
Provide expert input to protocols, informed consent forms, investigator’s brochures and clinical study reports; contribute to regulatory packages and engage with health authorities.
Support medical monitoring to uphold patient safety, protocol fidelity and high-quality data during trial conduct.
Analyze data from ongoing studies and the literature; synthesize evidence to inform go/no-go decisions, label-enabling strategies and lifecycle planning.
Ensure robust scientific input to therapeutic area standards and drive consistency and excellence across studies.
Provide scientific evidence to guide R&D, marketing, clinical and business development decisions.
Present protocols and scientific results to governance, investigators and key stakeholders; craft clear narratives that drive decision-making.
Organize and analyze clinical research to generate new hypotheses and shape future studies, collaborating with colleagues in late-stage and early development as well as medical affairs.