(Senior) Scientific Director, Clinical Development
2 weeks ago
Exicure, Inc. is seeking a motivated Scientific Director to join its expanding clinical development team. The Scientific Director will report to the Head of Clinical Development/Medical Lead and will provide scientific, clinical, and feasibility input to early and late stage clinical development programs with an emphasis on protocol development, study monitoring, and data interpretation and presentation. This role will work on rigorous design and execution of clinical studies, as well as lead systematic literature research and technical data analyses. The Scientific Director will serve as a point of contact for investigators and CROs in day-to-day clinical study needs. The candidate must be highly motivated, adept at problem solving, articulate, and collaborative.
Responsibilities:
* Drive clinical protocol development from high-level study concept to detailed protocol, supporting decisions regarding critical components of design (e.g. eligibility criteria, sample size, assessments) with appropriate literature review and discussions with key opinion leaders
* Monitor, analyze, and present safety, efficacy, pharmacodynamic, and pharmacokinetic data from clinical studies
* Aggregate and synthesize data from multiple sources - such as the clinical database, TLFs, and literature review - to provide integrated assessments of clinical study findings
* Develop scientific expertise in focused areas (e.g., selected functional assessments) to drive clinical development activities
* Formulate key messages and author clinical content for key documents including clinical study reports, investigator brochures, and publications (abstracts, posters, manuscripts)
* Engage with investigators, site staff, CROs, site monitors and patient/disease advocacy organizations to support ongoing clinical studies
* Author and review key documents to support clinical components of regulatory submissions (e.g., briefing documents, responses to queries, applications for expedited program designations)
* Develop presentations for meetings with internal/external stakeholders including advisory boards, Data Safety Monitoring Boards, Executive Steering Committees, and Board of Directors
* Collaborate within clinical development and cross-functionally on the creation and maintenance of the clinical development plan (CDP) ensuring alignment with the Target Product Profile (TPP) and accounting for feasibility and regional requirement
Education / Experience:
* Advanced scientific degree (Ph.D., Pharm D., or similar degree) required, with 5-8 years of experience supporting industry-sponsored clinical trials in the biopharmaceutical industry or clinical research setting
* Knowledge in the principles of good clinical practices (GCPs), clinical research methodology, statistics, data analysis and interpretation
* Familiar with scientific literature searches and weighing of quality peer-reviewed data
* Ability to clearly communicate to internal and external stakeholders orally and in writing (MS Word); effective knowledge of MS PowerPoint
* Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
* Prior neurology or pain experience highly preferre
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