5 дней назад
Executive Director, Clinical Development - Neurology (Gene Therapy)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Executive Director, Clinical Development - Neurology (Gene Therapy): Designing and implementing neurology gene therapy clinical development strategies and protocols across Phases 1–3 with an accent on medical leadership, clinical trial oversight, and regulatory communications. Focus on monitoring clinical data, maintaining study integrity, guiding cross-functional teams, and supporting gene therapy pipeline strategy.
Location: Fully remote from anywhere, with occasional domestic or international travel of approximately 20%. Candidates near the Bridgewater, New Jersey or San Diego, California facilities may choose mostly remote work with more in-person collaboration.
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Design and implement clinical development strategies and protocols for neurology gene therapy programs from first-in-human studies through full development.
- Lead the Neurology Gene Therapy clinical development team and collaborate with clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, quality, and biostatistics.
- Provide medical leadership for site selection, enrollment, feasibility, clinical monitoring, data cleaning, and issue escalation.
- Ensure the medical integrity of clinical study reports, data interpretation, regulatory submissions, and communications.
- Prepare safety and data monitoring committee charters and represent at regulatory and advisory committee meetings.
- Support scientific advisory boards, external clinical stakeholders, and the strategic direction of the gene therapy pipeline.
Requirements
- MD, DO, or foreign equivalent.
- 10+ years of global neurology clinical development experience in the pharmaceutical or biotechnology industry.
- Experience across Phases 1–3 of clinical research and 5+ years of management experience in clinical development.
- Prior gene therapy experience and clinical residency training in neurology.
- Knowledge of ICH-GCP and FDA regulatory guidelines.
- Ability to work remotely from anywhere and travel approximately 20% domestically or internationally.
Nice to have
- PhD in addition to the required medical degree.
- Pediatric clinical experience.
- Experience obtaining approvals for gene therapy products.
Culture & Benefits
- Fully remote work with purposeful in-person collaboration and occasional team travel.
- Medical, dental, vision, and mental health coverage, plus wellbeing reimbursement and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP participation, and company-paid life and disability insurance.
- Learning programs, mentorship, networking opportunities, employee resource groups, and service initiatives.
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