Clinical Scientist Director

Introduction to role

Lead the scientific design, delivery and interpretation of decisive clinical studies that determine benefit, risk and value in immunology. Partner closely with the study physician and a cross-functional team to ensure trial integrity, exemplary data quality, and a seamless safety evaluation process.

Accountabilities

• Clinical Trial Strategy and Design: Lead innovative design of Phase IIb and Phase III trials to answer decisive scientific and clinical questions aligned to program strategy.
• Scientific Leadership: Provide clinical and scientific guidance across one or more programs, ensuring strong hypotheses, endpoints and evidence plans.
• Data Integrity and Quality Metrics: Define quality metrics and data review plans for assigned studies; monitor trends to safeguard integrity and extract actionable insights.
• Safety Evaluation: Orchestrate an end-to-end safety evaluation process for pivotal trials, partnering with Patient Safety and study physicians to anticipate, detect and manage risk.
• Cross-Functional Delivery: Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, Patient Safety, and early development teams to deliver trials across geographies at pace.
• Regulatory Documentation and Interactions: Provide expert input to protocols, informed consent forms, investigator's brochures and clinical study reports; contribute to regulatory packages and engage with health authorities.
• Medical Monitoring Support: Support medical monitoring to uphold patient safety, protocol fidelity and high-quality data during trial conduct.
• Evidence Generation and Interpretation: Analyze data from ongoing studies and the literature; synthesize evidence to inform go/no-go decisions, label-enabling strategies and lifecycle planning.
• Therapeutic Area Standards: Ensure robust scientific input to therapeutic area standards and drive consistency and excellence across studies.
• Strategic Decision Support: Provide scientific evidence to guide R&D, marketing, clinical and business development decisions.
• Communication and Influence: Present protocols and scientific results to governance, investigators and key stakeholders; craft clear narratives that drive decision-making.
• Hypothesis Building: 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.

Essential Skills/Experience

• 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 immunology clinical development.
• Proven ability to work collaboratively in a cross-functional setting.
• Experience particularly in Phase II and Phase III clinical development.

Desirable Skills/Experience

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