Medical Director, Clinical Development – Neurology

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Provide leadership in clinical development for one or more programs.

• Contribute to the clinical development strategy in line with enterprise objectives and management.

• Act as the medical monitor for one or more studies.

• Conduct ongoing reviews and cleaning of clinical trial data in collaboration with clinical science and pharmacovigilance.

• Participate in and contribute to study team meetings.

• Present findings from clinical trials to management.

• Author clinical documents such as protocols and investigator brochures.

• Write clinical sections of regulatory documents (IND, CTA, NDA, MAA, or equivalent).

• Build and maintain relationships with key opinion leaders for clinical programs.

• Organize, manage, and lead Steering Committees, as well as participate in Strategic or Clinical Advisory Boards.

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

• Actively engage in the scientific, clinical, and commercial development of current and future product candidates.

• Play a role in fostering company culture and growth.

• Enhance communication, collaboration, and coordination with other functions.

• Maximize synergistic collaboration between Ono and Deciphera.

• Assist in the assessment of new internal or external targets by identifying clinical challenges and opportunities.

• Provide support for Medical Affairs activities as required.

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

• Serve as an internal resource for functions needing clinical input on specific drugs, including being the primary contact for clinical trial staff at study sites regarding clinical issues, regulatory matters, safety, and other functions.

⛳️ Requirements

• Medical Degree or equivalent with over 8 years of combined relevant academic and industry experience (post-medical school), including more than 3 years working on clinical trials.

• Proven experience in clinical trial design, execution, and medical monitoring.

• Strong understanding of GCP/ICH and regional/local regulations.

• Familiarity with data review and analytics tools (Rave, J-Review, Spotifre, etc.).

• Exceptional leadership, team collaboration, presentation, and communication skills, both written and oral.

• Ability to work collaboratively and flexibly with individuals at all levels within the organization.

• Proactive and effective work style, coupled with outstanding creative problem-solving abilities.

• Excellent strategic planning, organizational, and communication skills.

• Willingness to attend meetings across various time zones as required for the success of projects.

• Up to 30% travel may be necessary.

🏝️ Benefits

• Competitive salary along with an annual bonus.

• Comprehensive benefits package that includes medical, dental, and vision insurance, a 401(k) retirement plan with company matching, and more.

• Generous parental leave and family planning benefits.

• Exceptional company culture with opportunities for both personal and professional development.