Medical Director, Clinical Development – Neurology

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

📋 Description

• Lead clinical development at the study level for one or more clinical-stage assets in both early and/or late development.

• Contribute to the clinical development strategy that aligns with the goals of the enterprise 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 teams.

• Participate in and contribute to study team meetings.

• Present findings from clinical trials to management.

• Author protocols, investigator brochures, and the clinical sections of regulatory documents.

• Establish and maintain relationships with key opinion leaders.

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

• Assist in the development of manuscripts, publications, and other externally-facing documents.

• Contribute to the scientific, clinical, and commercial advancement of current and future product candidates.

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

• Support synergistic collaborations between Ono and Deciphera.

• Evaluate new internal or external targets by outlining clinical challenges and opportunities.

• Provide support for Medical Affairs activities as necessary.

• Engage in or coordinate cross-functional continuous improvement initiatives.

• Serve as an internal clinical resource and primary contact for clinical trial staff at study sites regarding clinical issues, as well as for regulatory, safety, and other functions.

• Depending on business needs, mentor and manage clinical scientists and assist in business development.

⛳️ Requirements

• Medical Degree or an equivalent qualification.

• Over 8 years of combined relevant academic and industry experience post-medical school.

• More than 3 years of experience working on clinical trials.

• Proficiency in clinical trial design, conduct, and medical monitoring.

• Knowledge of GCP/ICH guidelines and regional/local regulations.

• Familiarity with data review and analytics tools such as Rave, J-Review, and Spotfire.

• Exceptional leadership, teamwork, presentation, writing, and verbal communication skills.

• A collaborative and adaptable interpersonal approach.

• Capability to work proactively and efficiently with outstanding creative problem-solving abilities.

• Excellent strategic planning, organizational, and communication skills.

• Willingness to accommodate meetings across different time zones.

• Up to 30% travel may be required.

• Board certification in Neurology is preferred.

• Experience in Phase 3 clinical development is preferred.

• Experience interacting with the FDA and regulatory agencies outside the USA is preferred.

• Experience in basic or translational science is preferred.

🏝️ Benefits

• Equity-based compensation.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan with company matching.

• Life insurance.

• Flexible spending account for healthcare and/or dependent care.

• Annual performance bonus.

• Long-term incentive plan.

• Generous parental leave.

• Family planning benefits.

• Opportunities for personal and professional growth.