Job DescriptionThe 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
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
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
Additional InformationDeciphera 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:- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
