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.

Primary Duties

This individual will be a major contributor to defining global clinical strategy and providing clinical support for all neuroscience programs in research (eg, early CDP development, clinical support to CDT, including safety assessment) and development (at the level of asset team, program/trial development, site selection and enrollment, investigator engagement, site training, and clinical operations). This individual will contribute input and provide clinical support in regulatory interactions, will assist the Medical Affairs team, and will provide clinical support for strategic planning activities (such as clinical advisory boards). They will serve as primary clinical liaison with the investigative sites in safeguarding timely clinical trial enrollment and execution.

Responsibilities

Drives strategy and provide 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, eg, 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; engage and support 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; collaborate 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 (eg, 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, support global initiatives; 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.

Global travel required (approximately 40%)

Education and Experience Requirements

• MD/DO degree required, neurology training and clinical practice required, board certification preferred;
• 5 or more years of experience in 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; gene therapy, cellular therapy, and/or biologics experience a plus
• Proven track record of successfully conducting clinical studies resulting in regulatory support or approval
• This position is required to be in office 3 days per week.

Key Skills, Abilities, and Competencies

• Understanding of the drug development and approval process and clinical study design;
• Strong communication skills (written and oral); Excellent presentation skills required;
• Capable of representing Spark professionally with external therapy area experts, investigators, vendors, regulatory agencies, alliance partners, and others;
• Able to effectively engage with investigative sites and personnel;
• Ability to work effectively cross-functionally, and to serve as a clinical resource within Spark;
• Ability to mentor and develop staff regarding clinical and strategic challenges;
• Strong interpersonal and leadership skills required;
• Computer literacy (Microsoft Office).