Senior Clinical Research Director, I&I

Role Summary

The Senior Clinical Research Director (Sr CRD) is the primary clinical lead for programs, requiring a well-organized, strategic, and resourceful individual with strong emotional intelligence, self-motivation, analytical skills, and the ability to manage 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 documents, protocols); within a project, provide leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve study issues, anticipate potential issues, and share lessons learned across project teams
• Provide medical expertise to clinical 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 (Common Technical Document for FDA & EMA submission, filings in Japan and China, and responses to health authority questions)
• Provide medical input and support for activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, and interaction with investigators
• Internal governance: Preparation of documents and presentations for internal governance meetings
• Contribute to defining product value proposition (TVP), target product profile (TPP), and market access strategy, guiding research strategy based on clinical needs
• Represent projects at key regulatory agency meetings as medical spokesperson; lead clinical sections of regulatory submissions and provide support for registrations, label submissions, and modifications
• Review and/or contribute to clinical sections of Investigator’s brochure, clinical trial agreements, IND, DSUR, IND/ARIA, DRMP, and RMP
• Contribute to ad hoc tasks such as evaluating potential in-licensing candidates and serve as clinical advisor to research teams

Qualifications

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

Skills

• Clinical development leadership
• Medical strategy and regulatory interaction
• Cross-functional collaboration and governance
• Medical writing and data interpretation
• Stakeholder management and program leadership

Education

• Medical Doctor (MD) or equivalent required (preferred)

Additional Requirements

• Travel expectations not specified in the source
• Physical demands not specified in the source