Jobs · Information Technology · Massachusetts

Global Development Scientist, Associate Director

AstraZeneca · Waltham, MA · 2 wk ago
Information Technology$142k–$213k/yrFull-time

Accountabilities

  • Convert clinical strategy into study concept documents, protocols, and related materials; secure governance approval and maintain scientific integrity throughout.
  • Design and implement clinical trials, including studies involving immunotherapy and cell therapy approaches; assure quality conduct, timely delivery, and alignment with registration pathways.
  • Own the relevance and accuracy of the clinical science underpinning each study through deep literature assessment, expert consultation, and continuous data-driven refinement.
  • Lead clinical data review and cleaning; synthesize emerging evidence with the Medical Director to drive clear, actionable conclusions and next-step decisions.
  • Prepare and contribute clinical content for CSRs and regulatory documents (e.g., IB, DSUR, PSUR, NDA/BLA responses), enabling successful global submissions and inspections.
  • Lead or contribute as a technical expert to cross-functional projects advancing assets through all phases of development, from early signals to pivotal registration.
  • Build strong relationships with regulatory bodies and service providers; provide timely, high-quality responses to study sites on ICF updates, protocol clarifications, and EC/IRB queries.
  • Develop and deliver engaging investigator meetings and internal training, ensuring consistent understanding of study intent, endpoints, safety, and data expectations.
  • Participate in or lead evaluations of new opportunities and externally sponsored research to shape future portfolio decisions and collaborations.

Essential Skills/Experience

  • BS required
  • Minimum of 3 years of relevant experience
  • Industry or Academic experience in drug development required with experience in malignant haematology clinical trials strongly preferred.
  • Sufficient technical knowledge (haemato-oncology background preferred) to be able to interact with confidence with internal and external partners.
  • Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research.
  • Ability to drive/contribute to protocol design, writing and implementation.

Desirable Skills/Experience

  • Advanced degree (MS, PhD, PharmD, MD) in a relevant scientific or clinical discipline
  • Direct experience with immunotherapy and/or cell therapy trials in hematologic malignancies
  • Hands-on involvement in NDA/BLA or equivalent global submissions
  • Familiarity with translational biomarkers, novel endpoints, and innovative trial designs
  • Experience with global, multicenter studies and vendor oversight
  • Strong publication record and scientific communication skills
  • Proficiency in data-driven review methodologies and cross-functional decision forums

Benefits

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.

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