Medical Director, Clinical Development (Neurology)

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. Deciphera leverages its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. QINLOCK® (ripretinib) and ROMVIMZA® (vimseltinib) are approved kinase inhibitors for advanced gastrointestinal stromal tumor (GIST) and tenosynovial giant cell tumor (TGCT), respectively.

About the role

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. This individual will foster collaboration with allied functions through outstanding communication, collaboration, and coordination. Depending on business needs, the role may include mentorship and management of clinical scientists, contribution to business development, and continuous improvement activities.

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 actively 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.
  • Maximize synergistic collaboration between Ono and Deciphera.
  • Assess 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.

Requirements

• 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, Spotfire, 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 Qualifications

• Board certification in Neurology.
• Experience in Phase 3 of clinical development.
• Experience interacting with FDA and regulatory agencies outside of the USA.
• Experience in basic or translational science.

Pay

The base salary pay range for this role is $248,000–$341,000. Actual compensation will depend on various factors, including depth of experience, education, skillset, overall performance, and/or location.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, and vision insurance.
• 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.
• Equity-based compensation and long-term incentive plan.
• Flexible spending account for health care and/or dependent care.
• Life insurance.