Medical Director- Neurology

$201,800 - $302,800/Yr

Spark Therapeutics - Philadelphia, PA

Full-time - Senior

Philadelphia, PA

Ambulatory Health Care Services

About the position

Join the Spark Team, where we were born of innovation, springing from the curiosity, imagination, and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. We don't follow footsteps; we create the path. As a Medical Director in Neurology, you will play a pivotal role in defining global clinical strategy and providing clinical support for all neuroscience programs in research and development. This includes early Clinical Development Plan (CDP) development, clinical support to Clinical Development Teams (CDT), and safety assessments. You will contribute to asset team activities, program/trial development, site selection and enrollment, investigator engagement, site training, and clinical operations. Additionally, you will provide input and support in regulatory interactions and assist the Medical Affairs team in strategic planning activities, such as clinical advisory boards. Your role will also involve serving as the primary clinical liaison with investigative sites to ensure timely clinical trial enrollment and execution.

Responsibilities

• Drives strategy and provides insight for potential new clinical programs and projects based on medical need and development requirements.
• Leads the design of clinical programs and study protocols and contributes to their timely execution of all neuroscience clinical programs.
• Organizes and executes clinical advisory boards to enhance and focus scientific contents of the neuroscience programs in development.
• Provides clinical guidance to other R&D groups as needed, including nonclinical support, subject eligibility, adverse events, investigator questions, regulatory requests, statistical analyses, study design, and conduct.
• Initiates and develops professional relationships with external therapy area experts, investigators, and consultants.
• Serves as clinical liaison with investigative sites; engages and supports clinical trial sites, including education and training.
• Participates in site selection activities (including feasibility and initiation visits; other site visits as required) and other trial-related activities to safeguard enrollment targets and study timelines.
• Serves internally as clinical expert for global regulatory interactions; collaborates with Regulatory Affairs in planning regulatory strategy and communications.
• Participates in development and review of clinical documents, including position papers, protocols, study reports, regulatory documents (e.g., NDA, MAA responses, clinical summaries, and safety assessments).
• Provides input to Medical Affairs regarding publication and launch plans and participates in development of materials (slide decks, posters, manuscripts, abstracts), based on clinical trial data.
• Participates in development, review and/or presentation of clinical data in Training, Managed Care, or other presentations, as needed.
• Provides clinical expertise to commercial and global teams, as needed.
• Participates in advisory boards, supports global initiatives, and attends scientific meetings/presents data as needed.
• Contributes to critical evaluation of new business opportunities and potential new product candidates from a clinical/safety perspective; participates in due diligence activities.

Requirements

• MD/DO degree required, with neurology training and clinical practice required; board certification preferred.
• 5 or more years of experience in the pharmaceutical industry and/or clinical experience; global experience preferred.
• Prior pharmaceutical experience in neurology (Clinical Development or Medical Affairs) and prior experience in conducting clinical research preferred.
• Experience in gene therapy, cellular therapy, and/or biologics is a plus.
• Proven track record of successfully conducting clinical studies resulting in regulatory support or approval.

Nice-to-haves

• Experience with gene therapy and biologics is a plus.
• Strong interpersonal and leadership skills.

Benefits

• Competitive salary range from $201,800 to $302,800 based on education, training, and experience.
• Hybrid work model with 3 days in the office per week.