Senior Clinical Research Director, I&I

Role Summary

Senior Clinical Research Director (Sr CRD) for Immunology & Infectious Diseases (I&I) is the primary clinical lead for programs. The role requires a well-organized, strategically focused, resourceful individual with excellent emotional intelligence, self-motivation, strong analytical skills, and the ability to deliver across multiple operational tasks.

Responsibilities

• Act as a mentor for other CRDs and Clinical Scientists on the same project/therapeutic area
• Collaborate with functions to ensure a uniform, aligned operational approach (e.g., harmonizing study documents, essential study documents, protocols); lead, build consensus, and coordinate action plans with other CRDs and stakeholders to resolve project-related study issues; anticipate potential issues and share lessons learned across project teams; raise study or project-level issues to TA Heads as relevant
• Provide medical expertise to clinical studies and/or registries (e.g., protocol, key results, Clinical Study Report), excluding select Exploratory Pharmacology studies
• Support other clinical development activities (e.g., pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
• Contribute to the clinical part of submission dossiers (Common Technical Document for FDA & EMA submissions, filing in Japan and China, and responses to questions from health authorities)
• Provide appropriate medical input and support for all activities related to clinical studies—such as medical training, feasibility, medical review of data, medical information for the study team, and coordination with medical advisors/Clinical Project Leaders from Clinical Study Units and investigators
• Internal governance: Preparation of documents and presentations for internal governance meetings
• Contribute to defining the product value proposition (TVP), target product profile (TPP), and market access strategy in collaboration with respective functions, influencing the focus of the research strategy
• Represent the project at key regulatory agency meetings as the medical spokesperson; lead the clinical sections of regulatory submissions (BLA/CTD), briefing packages for regulatory meetings, and PSP/PIP; support registrations, label submissions and modifications
• Review and/or contribute to clinical sections of documents such as Investigator’s Brochure, CTA, IND, DSUR, INDAR, DRMP, and RMP
• Contribute on an ad hoc basis to tasks such as evaluating potential in-licensing candidates for the I&I therapeutic area and serve as the clinical advisor to research teams

Qualifications

• Preferred: Medical Doctor (MD) — GP or specialist; English fluent (spoken and written)
• Required: At least 4 years in pharmaceutical industry or CRO, with previous experience in clinical development

Skills

• Emotional intelligence
• Self-motivation
• Analytical skills
• Ability to deliver on multiple operational tasks