Medical Director, Clinical Development (Neurology)

The medical director will provide clinical development leadership at the study level for one or more clinical stage assets in early and/or late development. To achieve development goals this individual will foster collaboration with allied functions through outstanding communication, collaboration and coordination. Depending on business needs, the role could include mentorship and management of one or more clinical scientists as well as contribution to business development and continuous improvement activities. 

Key Responsibilities: 

• Provide clinical development leadership to one or more programs 75%  

• Contribute to clinical development strategy in alignment with enterprise goals and management 

• Serve as medical monitor for one or more studies 

• Perform ongoing clinical trial data review and cleaning in collaboration with clinical science and pharmacovigilance 

• Attend and contribute to study team meetings 

• Present clinical trial findings to management 

• Author clinical documents (protocol, investigator brochure) 

• Author clinical portions of regulatory documents (IND, CTA, NDA, MAA or equivalent) 

• Develop and manage relationships with key opinion leaders for clinical programs 

• Organize, manage and lead Steering Committees and contribute to Strategic or Clinical Advisory Boards 

• Contribute to writing of manuscripts, publications, or other documents intended for external audiences 

• Contribute in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates 

• Contribute to company culture and growth 25% 

• Foster communication, collaboration and coordination with other functions 

• Contribute to maximizing synergistic collaboration between Ono and Deciphera 

• Contribute to assessment of new internal or external targets by outlining clinical challenges and opportunities 

• Support Medical Affairs activities as needed 

• Participate in and/or coordinate cross-functional continuous improvement projects 

• Act as an internal resource for functions requiring clinical input on select drug(s) including primary point of contact for clinical trial staff at study sites for clinical issues as well as regulatory, safety and other functions