Sr. Director - Clinical Affairs

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Role Summary

The Sr Director, Clinical Affairs plays a critical role in supporting the Clinical Development (CD) team by providing scientific and technical expertise and will bring experience in designing and conducting clinical trials. This position serves as a liaison between CD and other cross-functional groups and is responsible for setting and implementing strategies across the CD program, providing oversight of strategic study design, study start up, CRO and vendor management, clinical data and safety monitoring, analysis and reporting of studies.

Responsibilities

• Collaborate with CD to review and author study protocols, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, and responses to support interactions with US and Global Health Authorities
• Serves as CD/medical monitor (MM) liaison/point-of-contact for inquiries from both internal and external stakeholders, clinical sites, vendors, clinical research organizations (CROs), etc., collaborates with others in the review of safety narratives and other safety-related guidelines and documentation, supports the Clinical Trial Liaison Team (CTL) by providing timely clinical/medical responses to sites
• Identifies and mitigates protocol risks, performs ongoing review and monitoring of protocol deviations (PDs), drives PD review meetings, and develops strategies for protocol retraining and improving site compliance
• Writes and/or reviews content for protocol training, site initiation visits, and investigator/study coordinator meetings, clinical presentation slides, scientific meetings, conferences, other events and presentations, and contributes to scientific publication of study results as needed
• Contributes as CD/MM representative during clinical system updates (EDC/IRT)
• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, study coordinators, clinicians, health authorities, scientists and KOLs, as well as internal groups, including regulatory, clinical operations, data management, data analytics/visualization, biostatistics, clinical supply, and quality
• Uses CD/MM expertise to perform ongoing clinical data review
• Participates in ongoing enhancements and development of team processes, structures, and tools, while supporting the development and training study team members

Qualifications

• Required: 10+ years of clinical research and/or clinical development experience within the pharmaceutical or biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of fore mentioned.)
• Preferred: PhD; PharmD with relevant experience may be considered
• Preferred: Gene therapy and/or ophthalmology (retina) experience
• Preferred: Ability to proactively predict issues and solve problems
• Preferred: Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
• Preferred: Diplomacy and positive influencing abilities
• Preferred: Committed to developing and mentoring team
• Preferred: Therapeutic area knowledge relevant to mechanism of action and retinal drug development
• Preferred: Understanding of US and Global Regulatory requirements