This individual will be directly, and through the team, responsible for developing global clinical strategies and providing clinical support for all neurology (and other therapeutic areas, as necessary) programs as Clinical Development Lead (eg, program/trial development, site selection and enrollment, investigator engagement, site training, clinical operations). This leader will develop plans that deliver medically differentiated therapies which provide meaningful improvements to patients. The Clinical Development Lead is a core member of the Asset/Life Cycle Team and is responsible for overseeing and developing global gene therapy development strategies and disease intervention strategies and ensuring their effective and efficient execution. The individual will guide the development of gene therapies and programs, approve Clinical Development Plans and priorities, and lead the design and final interpretation and completion of clinical studies. The individual as Clinical Development Lead will provide clinical development support and guidance into global regulatory interactions, will assist the Medical Affairs team, as necessary, and will provide clinical support for strategic planning activities (including clinical advisory boards). The individual will serve as a scientific, medical, and strategic expert both internally and externally.

Responsibilities

• Plays a leadership role in providing clinical science and broader development input into the relevant therapeutic area clinical scientific strategy, as well as into relevant cross-functional and enterprise-wide plans, strategies and initiatives.
• Leads global clinical strategy development for gene therapies in neuroscience.
• 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 clinical study protocols and ensures timely execution of all neuroscience clinical programs.
• Leads the Development Subteam, a strategic team that integrates functional perspectives to define and implement a robust and technically sound Clinical Development Plan to deliver innovative treatment options using an integrated gene therapy platform for patients suffering from CNS disorders.
• Evaluates possible needs and oversees creation and implementation of companion diagnostic opportunities and plans in neuroscience gene therapy development plans.
• 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 and Technology 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.
• Oversees and 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 development 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).
• Drives and integrates ongoing evidence/data generation, including clinical studies, Medical Affairs studies, Real World Evidence, and other types of evidence.
• 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.
• Other duties as assigned or as business needs require.

Education and Experience Requirements

• MD/DO degree required, neurology training and clinical practice preferred, board certification preferred.
• 10+ years of experience in pharmaceutical industry and/or a recognized expert in the field (in which case a minimum of 4 years industry experience); global experience preferred.
• 4 or more years’ experience managing medical/clinical staff.
• 5 or more years’ experience with clinical trials.
• 2 or more years’ experience submitting NDAs/BLAs to regulatory authorities in Europe and/or the US.
• 4 or more years’ experience authoring global clinical development plans.
• 4 or more years’ experience publishing results of clinical drug trials in referred journals.
• In-depth understanding of Phase 1 to 4 drug development.
• Multidisciplinary experience in the pharma/biotech industry is strongly preferred (eg, research, regulatory, clinical operations, business development, commercial operations).
• Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (eg, ISS, ISE, competitor data).
• Comprehensive understanding of product and safety profiles.
• In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.
• In-depth understanding of competitive activity in the field.

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.
• Ability to stay abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease areas.
• Computer literacy (Microsoft Office).