Contact: Alexandra Spink - [email protected]
No 3rd party candidates
Location: Bridgewater, NJ (Onsite)
We are looking for an accomplished Executive Medical Director, Neurology Clinical Development to lead the strategy, execution, and oversight of global clinical development programs across neurology indications. This highly visible leadership role will drive clinical programs from early development through registration, provide medical leadership across cross-functional teams, and help shape the future of our neurology gene therapy portfolio.
As the medical lead for assigned programs, you will provide expert oversight of medical monitoring, clinical strategy, data interpretation, regulatory interactions, and scientific communications. Working collaboratively across Research, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Commercial, and other key stakeholders, you will play a critical role in advancing innovative therapies for patients with neurologic diseases.
Key Responsibilities
- Lead the strategic planning, design, and execution of global clinical development programs across all phases of development (Phase I–III), ensuring the successful delivery of high-quality clinical studies.
- Serve as the therapeutic area lead for the Neurology Gene Therapy Clinical Development team, partnering closely with leaders across Clinical Operations, Toxicology, Regulatory Affairs, Commercial, Pharmacovigilance, Clinical Quality, and Biostatistics.
- Provide medical oversight and monitoring for clinical trials, ensuring patient safety, protocol compliance, data integrity, and overall study quality.
- Lead clinical operational strategy related to site selection, enrollment, feasibility assessments, and study execution, serving as the primary medical escalation point for issues that may impact study quality or timelines.
- Collaborate with Clinical Operations on medical monitoring, coding, safety review, and data cleaning activities.
- Interpret clinical trial data and ensure the scientific accuracy and medical integrity of clinical study reports, presentations, and communications.
- Author or oversee the preparation of clinical sections for regulatory submissions, including INDs, NDAs, BLAs, briefing books, and other regulatory documents.
- Represent the company during interactions with regulatory agencies, including FDA meetings, Advisory Committee presentations, and other health authority engagements.
- Develop or oversee safety management documents, including Data Monitoring Committee (DMC) charters, safety management plans, investigator communications, and other study-specific documents.
- Prepare or review Serious Adverse Event (SAE) reports and Investigator Alert Letters in collaboration with Clinical Operations, as needed.
- Build and maintain strong relationships with CROs, investigators, clinical consultants, key opinion leaders (KOLs), investigational sites, and other external partners supporting clinical development.
- Analyze, interpret, and communicate clinical data through presentations, publications, scientific meetings, and advisory boards.
- Organize and lead Scientific Advisory Board meetings and Data Monitoring Committee meetings.
- Maintain current expertise in neurology, gene therapy, and emerging scientific advances through ongoing literature review and participation in scientific and medical conferences.
- Develop and manage clinical development budgets while providing regular updates on program progress, timelines, and key risks.
- Serve as an active member of the Gene Therapy Leadership Team, contributing to the strategic direction of the business and identifying future opportunities and potential challenges.
- Support business development initiatives, product evaluations, licensing opportunities, and due diligence activities.
- Provide medical and clinical expertise to internal stakeholders, including Research & Development, Commercial, Marketing, Manufacturing, Market Access, Patient Services, Regulatory Affairs, and Legal, as well as external stakeholders such as healthcare professionals, advocacy groups, and data monitoring committees.
- Coach, mentor, and develop direct reports while fostering a collaborative, high-performing clinical development organization.
Qualifications
- MD (or foreign equivalent) with clinical training and experience in Neurology required.
- PhD in a related scientific discipline preferred.
- Minimum of 10 years of clinical development experience within the pharmaceutical or biotechnology industry, including global clinical programs across Phases I–III.
- Minimum of 5 years of leadership experience managing clinical development teams.
- Clinical residency training in Neurology required.
- Pediatric neurology experience preferred.
- Gene therapy experience preferred.
- Demonstrated expertise in medical monitoring, clinical trial design, regulatory strategy, and interpretation of clinical data.
- Strong knowledge of ICH-GCP guidelines, FDA regulations, and global clinical development requirements.
- Proven ability to lead cross-functional teams, influence executive stakeholders, and successfully manage complex clinical development programs.
- Excellent scientific communication, presentation, and leadership skills.
- Willingness to travel domestically and internationally up to 20%.
