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
Required Qualifications
Medical Degree or equivalent with 8+ years of combined relevant academic and industry experience (post-medical school), including 3+ years of work on clinical trials.
Experience with clinical trial design, conduct, and medical monitoring
Understanding of GCP/ICH and regional/local regulations
Familiarity with data review/analytics tools (Rave, J-Review, Spotifre, etc)
Outstanding leadership, team, presentation, written and oral skills
Collaborative and flexible in personal interactions at all levels of the company
Ability to work proactively and effectively, with exceptional creative problem-solving skills
Excellent strategic planning, organizational and communication skills
Willingness to accommodate meetings across time zones as needed for project success
Up to 30% travel
Preferred Capabilities
Board certification in Nuerology
Experience in phases 3 of clinical development
Experience interacting with FDA and regulatory agencies outside of the USA
Experience in basic or translational science
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $248,000-$341,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)
Benefits:
Equal Employment Opportunity Information
Deciphera is committed to equal employment opportunity and values diversity. To help us meet reporting requirements, we invite you to complete the confidential survey at the end of this application. Providing this information is entirely optional. It will not be used in the hiring process and will have no impact on your opportunity for employment. The information will be treated confidentially. Deciphera is committed to making all hiring and employment decisions fairly and on a non-discriminatory basis.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
