We’re looking for a candidate to this position in an exciting company.
Develop and manage product profiles and Clinical Development Plans; lead the design, development and implementation of innovative clinical trials for novel drug candidates and biosimilars, from translational stage through global Phase 2 trials and registration.
Lead Clinical Development efforts with aggressive, creative but realistic approaches to drug development across multiple therapeutic areas and product modalities
Apply state-of-the-art knowledge of disease mechanisms to selection of possible biomarkers, pharmacodynamic endpoints, and patient stratification considerations to support innovative clinical study designs for novel products.
Maintain the highest quality clinical programs, following GCP and ICH guidelines. Manage timely reporting of safety signal to regulatory authorities and the generation of clinical study reports.
Communicate regularly and effectively with senior leaders across the R&D organization
Lead clinical team to secure global regulatory approvals for pipeline products
MD with 7+ years of industry experience
Experience in clinical rare diseases or oncology
Proven track record of successful drug development; experience with Phase 1 through Phase 3 trials
Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills
Shows fresh, insightful thinking by developing creative approaches to processes and practices, products & solutions, services, business models & strategy