Senior Medical Director Neurology

$235,700 - $353,500/Yr

Spark Therapeutics - Philadelphia, PA

Full-time - Senior

Philadelphia, PA

Ambulatory Health Care Services

About the position

The Senior Medical Director - Neurology at Spark Therapeutics is responsible for developing global clinical strategies and providing clinical support for neurology programs. This role involves overseeing gene therapy development strategies, guiding clinical studies, and ensuring effective execution of clinical development plans. The individual will serve as a scientific and strategic expert, collaborating with various teams and external partners to enhance the development of innovative therapies for CNS disorders.

Responsibilities

• Develop global clinical strategies for gene therapies in neuroscience.
• Lead the design of clinical programs and study protocols, ensuring timely execution of neuroscience clinical programs.
• Oversee the Development Subteam to implement a robust Clinical Development Plan for gene therapy.
• Evaluate and implement companion diagnostic opportunities in neuroscience gene therapy development plans.
• Organize and execute clinical advisory boards to enhance scientific content of neuroscience programs.
• Provide clinical guidance to R&D and Technology groups on various clinical aspects.
• Initiate and develop relationships with external therapy area experts and investigators.
• Serve as clinical liaison with investigative sites, supporting education and training.
• Collaborate with Regulatory Affairs on regulatory strategy and communications.
• Participate in the development and review of clinical documents and regulatory submissions.
• Drive ongoing evidence/data generation, including clinical studies and Real World Evidence.
• Provide input to Medical Affairs regarding publication and launch plans.
• Participate in the development and presentation of clinical data for various audiences.
• Provide clinical expertise to commercial and global teams, attending scientific meetings as needed.

Requirements

• MD/DO degree required, with neurology training and clinical practice preferred.
• 10+ years of experience in the pharmaceutical industry or recognized expertise in the field, with a minimum of 4 years in the industry.
• 4+ years of experience managing medical/clinical staff.
• 5+ years of experience with clinical trials.
• 2+ years of experience submitting NDAs/BLAs to regulatory authorities in Europe and/or the US.
• 4+ years of experience authoring global clinical development plans.
• 4+ years of experience publishing results of clinical drug trials in peer-reviewed journals.
• In-depth understanding of Phase 1 to 4 drug development.
• Multidisciplinary experience in the pharma/biotech industry preferred.
• Broad experience in data analysis and interpretation relevant to clinical trials.
• Comprehensive understanding of product and safety profiles.
• In-depth knowledge of GCP, ICH, FDA, EMEA, NICE guidelines and regulations.

Nice-to-haves

• Experience in gene therapy development.
• Familiarity with CNS disorders and related therapeutic areas.

Benefits

• Competitive salary range from $235,700 to $353,500.
• Equal opportunity employer with a commitment to diversity and inclusion.
• Reasonable accommodations for individuals with disabilities.