Senior Clinical Research Director, I&I

Role Summary

Senior Clinical Research Director (Sr CRD) is the primary clinical lead for programs. The role requires a well-organized, strategically focused, resourceful individual with excellent emotional intelligence, self-motivation and solid analytical skills who can deliver across multiple operational tasks. The Sr CRD provides medical leadership across clinical studies and collaborates with cross-functional teams to guide development and regulatory activities.

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 documents, protocols); lead, build consensus, and coordinate action plans with other CRDs and stakeholders to resolve project-related study issues; anticipate potential issues across project or study teams; raise issues to TA Heads as relevant.
• Provide medical expertise to the clinical studies and/or registries (e.g., protocol development, interpretation of Key Results, Clinical Study Report).
• Support other clinical development activities (e.g., feasibility assessments, medical review and validation of clinical data, study risk assessment).
• Contribute to the clinical portion of submission dossiers for projects (e.g., Common Technical Document for FDA/EMA submission; filings in Japan and China; responses to health authority questions).
• Provide medical input and support for activities related to clinical studies such as medical training, feasibility, data review, medical information for the study team, and interaction with investigators and medical advisors/Clinical Project Leaders from Clinical Study Units.
• Internal governance: prepare documents and presentations for internal governance meetings.
• Contribute to defining the product value proposition (TVP), target product profile (TPP) and market access strategy, by providing input on clinical needs and development strategies for research projects.
• Represent the project at key regulatory agency meetings as the medical spokesperson; lead the clinical sections of regulatory submissions (BLA/CTD); prepare briefing packages for regulatory meetings; support registrations, label submissions and modifications; take on CRD responsibilities as needed.
• Review and/or contribute to the 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 evaluation of potential in-licensing candidates for the I&I therapeutic area and serve as the clinical advisor to research teams.

Qualifications

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