Senior Clinical Research Director, I&I

Role Summary

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

Responsibilities

• Act as a mentor for other CRDs and Clinical Scientists on a same project/TA
• Collaborate with functions to ensure uniform, aligned operational approach (e.g., harmonizing study documents, essential documents, protocols)
• Within a project, provide leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve study issues, anticipate potential issues, share lessons learned across project teams
• Raise study or project-level issues to TA Heads and share relevant information within and beyond project teams
• Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (e.g., protocol, Key Results, Clinical Study Report)
• 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 for their projects (Common Technical Document for FDA & EMA submission, filing in Japan and China, and responses to health authority questions)
• Provide appropriate medical input and support for all activities related to clinical studies (medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators)
• Internal governance: preparation of documents and presentations for internal governance meetings
• Contribute to the definition of the product value proposition (TVP), TPP and market access strategy in collaboration with respective functions, guiding 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, PSP/PIP; support registrations, label submissions and modifications
• Review and/or contribute to the clinical section of documents such as the 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

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

Education

• Medical Doctor (MD)