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 for 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 medical expert, collaborating with various teams and external stakeholders to enhance the development of innovative therapies for patients with 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.
• Organize clinical advisory boards to enhance scientific content of neuroscience programs.
• Provide clinical guidance to R&D and Technology groups on various aspects of clinical trials.
• 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 presentation of clinical data in various forums.
• Provide clinical expertise to commercial and global teams 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 is strongly preferred.
• Broad experience in data analysis and interpretation.

Nice-to-haves

• Board certification preferred.
• Global experience preferred.

Benefits

• Competitive salary range from $235,700 to $353,500 based on education, training, and experience.