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 multiple clinical-stage assets in both early and late development phases.

• Promote teamwork with associated functions through effective communication, collaboration, and coordination.

• Mentor and supervise one or more clinical scientists as required.

• Contribute to business development initiatives and continuous improvement efforts.

• Assist in formulating clinical development strategies that align with organizational objectives and management directives.

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

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

• Participate in and provide input during study team meetings.

• Present findings from clinical trials to management.

• Prepare clinical documents, such as protocols and investigator brochures.

• Write the clinical sections of regulatory documents, including IND, CTA, NDA, and MAA submissions.

• Establish and maintain relationships with key opinion leaders.

• Organize, oversee, and lead Steering Committees while contributing to Strategic or Clinical Advisory Boards.

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

• Support Medical Affairs initiatives as necessary.

• Engage in or manage cross-functional continuous improvement projects.

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

• Encourage communication and collaboration across functions and between Ono and Deciphera.

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

⛳️ Requirements

• Medical Degree or an equivalent qualification.

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

• At least 3 years of experience working on clinical trials.

• Proficient in clinical trial design, execution, and medical monitoring.

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

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

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

• A collaborative and adaptable interpersonal style.

• Ability to work proactively and effectively with outstanding creative problem-solving capabilities.

• Strong strategic planning, organizational, and communication abilities.

• Openness to accommodate meetings across various time zones.

• Board certification in Neurology is preferred.

• Experience in Phase 3 clinical development is preferred.

• Background in interacting with the FDA and regulatory agencies outside of the USA is preferred.

• Experience in basic or translational science is preferred.

🏝️ Benefits

• Equity-based compensation.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan with company matching contributions.

• Life insurance coverage.

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

• Annual performance bonus.

• Long-term incentive plan.

• Generous parental leave policy.

• Family planning benefits.

• Opportunities for both personal and professional development.

• Up to 30% travel is required.