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AstraZeneca

Global pharmaceutical company developing prescription medicines

Senior Group Director - Clinical Scientist, Immunology

Clinical Research OperationsPosted on Nov 10
Full-timeCambridge, MA, USA

About the Job

Requirements

  • An advanced clinical or scientific degree, such as a PhD, PharmD, MD, or equivalent qualification in a relevant life-sciences discipline.
  • Typically 10 or more years of relevant clinical-development experience, including substantial experience leading clinical programs or complex studies and delivering through global matrix teams.
  • Demonstrated line-management experience, including talent selection, objective setting, performance and development conversations, resource allocation, and coaching of scientists at different career stages.
  • Deep knowledge of end-to-end clinical and pharmaceutical drug development, clinical-trial methodology, benefit-risk evaluation, and global regulatory expectations.
  • Proven authorship, leadership, or senior review of clinical development plans, protocols, amendments, Investigator’s Brochures, informed consent forms, safety documents, regulatory materials, analysis plans and outputs, and Clinical Study Reports.
  • Extensive experience with clinical and safety data review, interpretation of integrated evidence, and preparation of decision-quality recommendations for governance and senior leadership.
  • Working knowledge of International Council for Harmonisation Good Clinical Practice, inspection readiness, global health-authority expectations, and clinical quality systems.
  • Ability to manage multiple priorities, make sound judgments with incomplete information, and maintain a high standard of scientific and operational quality.
  • Clinical-development expertise in one or more immunology disease areas and experience with innovative therapeutic modalities, including cell therapy, biologics, or other advanced therapies.
  • Ability to travel nationally and internationally as required.

Responsibilities

  • Line-manage Clinical Scientists across recruitment, onboarding, objectives, performance, succession, career development, retention, and project and study allocation.
  • Build an inclusive, high-performing team through clear expectations, feedback, coaching, mentorship, development plans, and appropriate delegation and oversight.
  • Balance portfolio demand, capability, development opportunities, and business priorities; anticipate capacity and skill gaps and propose practical resourcing solutions.
  • Contribute to departmental leadership, operating-model decisions, talent and resource reviews, issue resolution, and non-drug scorecard priorities; may serve as Clinical Science Skills Lead, strengthening procedures, training, communities of practice, and continuous improvement in quality, consistency, efficiency, and inspection readiness.
  • Provide portfolio-level Clinical Science insight to prioritize work, connect evidence needs across programs, and guide transparent trade-offs and resource decisions.
  • Partner with the Clinical team to shape strategy and execution; lead or support the Clinical Development Plan in alignment with the Target Product Profile, disease strategy, patient needs, and emerging evidence.
  • Influence Global Project Teams and senior governance through evidence-based recommendations that clarify uncertainties, benefit-risk, operational implications, and decision points; resolve cross-functional issues and lead or support external alliances with clear expectations, governance, and risk management.
  • Lead clinical study design and delivery aligned with the Clinical Development Plan, ensuring objectives, endpoints, estimands, assessments, and operational choices generate decision-enabling evidence.
  • Lead or provide senior review of strategic study documents and translate protocol intent into practical site and data-collection workflows; guide study teams and external partners through clear cross-functional accountabilities and risk-based oversight.
  • Oversee clinical data review, eligibility, data cleaning, and analysis readiness; ensure traceability from endpoints to outputs and integrate efficacy, safety, pharmacokinetic/pharmacodynamic, biomarker, and translational evidence into clear recommendations with the responsible Physician or Clinical Lead.
  • Partner with the Study Physician and Pharmacovigilance on safety surveillance, reconciliation, aggregate trends, and safety-review materials; escalate findings requiring medical judgment and ensure documented issue closure, regulatory compliance, and inspection readiness.
  • Lead or review Clinical Science contributions to regulatory submissions, health-authority interactions, publications, and scientific disclosures; maintain consistency across outputs, translate external developments into strategy, and represent Clinical Science with external stakeholders.

Desired Qualifications

  • Experience leading a discipline, skill group, community of practice, or departmental capability initiative.
  • Experience with portfolio planning, departmental resource management, operating-model design, or delivery of functional scorecard objectives.
  • Experience leading external alliances or collaborations with academic institutions, investigators, consortia, service providers, contract research organizations, or strategic partners.
  • Understanding of translational medicine, biomarkers, clinical pharmacology, biostatistics, data science, safety, regulatory, chemistry, manufacturing, and controls, and commercial considerations across the development lifecycle.
  • External scientific credibility demonstrated through publications, presentations, professional networks, or recognized contribution to the field.
  • Familiarity with clinical review and analytics tools, including artificial intelligence, and with data-analysis environments.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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