Executive Medical Director, Neurology Clinical Development - Gene Therapy #3635450

Job Description

Job Description

Be Part Of A High-Performing Team:

Join a science-driven biopharmaceutical organization focused on developing innovative therapies for patients with serious and underserved diseases. This senior medical leader will become part of a highly collaborative clinical development organization that brings together experts across clinical operations, regulatory affairs, pharmacovigilance, biostatistics, toxicology, clinical quality, research, and commercial strategy.

The team is advancing complex clinical programs across neurology and gene therapy while evaluating opportunities to expand the broader development pipeline. This role offers significant visibility and influence across clinical strategy, portfolio planning, regulatory interactions, and organizational leadership.

What's In Store For You:

• Engagement: W2 only; no C2C or 1099 arrangements.
• Lead global neurology clinical programs from first-in-human studies through late-stage development and regulatory submission.
• Shape clinical development strategy for innovative gene therapy programs.
• Influence pipeline expansion, portfolio decisions, and external asset evaluations.
• Represent the organization in regulatory meetings, advisory committees, scientific forums, and external partnerships.
• Build, coach, and develop a high-performing clinical development team.
• Travel domestically and internationally approximately 20%.

How You Will Make An Impact:

• Develop and execute global clinical development strategies for neurology programs across Phase 1 through Phase 3.
• Design scientifically rigorous clinical protocols and guide programs from first-in-human studies through full clinical development.
• Serve as the therapeutic area medical lead for neurology gene therapy programs.
• Partner with clinical operations, regulatory affairs, toxicology, pharmacovigilance, biostatistics, clinical quality, research, and commercial teams.
• Provide medical monitoring and oversight for assigned clinical studies.
• Review safety information, medical coding, data-cleaning activities, protocol deviations, and emerging clinical data.
• Lead the interpretation and communication of clinical trial results.
• Provide medical leadership for site selection, enrollment planning, feasibility assessments, and study execution.
• Serve as the primary escalation point for medical or operational issues that may affect study quality, integrity, or patient safety.
• Ensure the medical and scientific accuracy of clinical study reports, regulatory communications, publications, and presentations.
• Author or oversee clinical sections of INDs, briefing documents, BLAs, NDAs, and other global regulatory submissions.
• Represent the organization during regulatory authority meetings, including advisory committee presentations when required.
• Prepare or oversee safety charters, data monitoring committee charters, investigator alert letters, serious adverse event reports, and medical management plans.
• Lead interactions with investigators, CROs, clinical consultants, advocacy organizations, data safety monitoring boards, and investigational sites.
• Organize and participate in scientific advisory boards and data monitoring committee meetings.
• Maintain current expertise in neurological diseases, gene therapy developments, competitor programs, and emerging clinical data.
• Analyze and organize clinical data for regulatory presentations, scientific publications, and internal decision-making.
• Manage clinical development budgets, timelines, resources, and program progress.
• Support business development, product evaluation, pipeline expansion, and clinical due diligence.
• Provide medical and clinical expertise to commercial, market access, manufacturing, patient services, legal, regulatory, and research teams.
• Recruit, coach, mentor, and develop clinical development professionals.
• Participate in senior leadership discussions regarding business strategy, portfolio opportunities, and potential development risks.

Do You Have the Expertise to Lead Global Neurology Clinical Development?

• Medical degree or recognized foreign equivalent with clinical experience is required.
• Completion of clinical residency training in neurology is required.
• At least 10 years of global clinical development experience within the pharmaceutical or biotechnology industry.
• Experience leading programs across multiple stages of clinical research, including Phase 1, Phase 2, and Phase 3.
• At least 5 years of management or clinical development leadership experience focused on neurology.
• Demonstrated experience developing clinical strategies, clinical development plans, and study protocols.
• Strong medical monitoring and clinical safety oversight experience.
• Experience reviewing and interpreting clinical trial data.
• Regulatory submission experience involving INDs, briefing books, BLAs, NDAs, or comparable global submissions.
• Strong knowledge of ICH-GCP requirements and FDA regulatory guidelines.
• Proven ability to lead multidisciplinary teams and influence senior clinical, regulatory, scientific, and business stakeholders.
• Strong executive communication, scientific presentation, decision-making, and problem-solving skills.
• Experience managing clinical development budgets, timelines, and competing priorities.
• Gene therapy clinical development experience is preferred.
• Pediatric clinical development experience is preferred.
• Ophthalmology or neuro-ophthalmology development exposure is beneficial.
• A PhD in addition to the required medical degree is preferred.
• Ability to travel domestically and internationally approximately 20%.