Associate Medical Director, Liver-Directed (systemic)

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

 

Primary Duties

The Associate Medical Director (AD), Clinical Development will be responsible for directing assigned liver-directed (systemic) gene therapy early phase clinical development programs across Spark. This role will be accountable, working in collaboration with the Development Sub-team Lead, for planning the full clinical trial program to meet the Target Product Profile and regulatory requirements, clinical trial design, execution and completion of studies, publication of study results and preparation of clinical sections of regulatory submissions.  S/He/They will also serve as the Medical Monitor on clinical studies and contribute to trial site selection and enrollment, investigator engagement and site training. The AD  will be responsible for clinical guidance in developing liver-directed (systemic) gene therapy platforms within the organization and will serve as a scientific, medical and strategic expert both internally and externally.

 

Responsibilities

As a key member of the Development SubTeam (DevST), the incumbent will be responsible for implementing the Clinical Development Plan (CDP) for assigned programs to include:

• Collaborating with cross-functional project team members in planning, conducting and evaluating clinical trials for assigned programs .This includes being responsible for the preparation and review of relevant components of study related documents such as Protocols, Investigator’s Brochure, Clinical Study Reports and Regulatory documents (IND/CTA filings, regulatory document updates [e.g. DSUR, and information requests from Health Authorities])
• Serving as Medical Monitor for assigned clinical trials conducting ongoing review of medical/safety data and ensuring correct medical/scientific data interpretation for study reporting
• Serving as clinical liaison with investigative sites; engage and support clinical trial sites, including education and training. Participate in site selection activities (including feasibility and initiation visits; other site visits as required) and other trial-related activities to achieve enrollment targets and study timelines
• Serve as internal as clinical expert for global regulatory interactions; collaborate with Regulatory Affairs in planning regulatory strategy and communications
• Planning and management of investigator meetings, advisory boards and other scientific committees (e.g independent reviews, Joint Monitoring Committees)
• Analyzing and synthesizing clinical data for internal decision making, publication and regulatory filings
• Acting as a regular reviewer/presenter to various internal committees
• Maintaining the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

• Provide clinical input and work cross-functionally with the Research and Translational Sciences groups to help develop optimal strategies for managing liver-directed gene therapy immune responses
• Work with external experts and organize forums to help inform strategies for mitigating liver-directed gene therapy immune responses
• Initiate and develop professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities
• Provide input to Medical Affairs regarding global publication and launch plans and participate in development of materials (slide decks, posters, manuscripts, abstracts), based on clinical trial data for their projects
• Provide clinical expertise to Research, Commercial, Business Development and global teams, as needed
• Participate in advisory boards, support global initiatives, as needed
• Attend scientific meetings/present data on their projects, as needed
• Other duties as assigned or as business needs require.
• This position will be on site 3 days per week in Philadelphia

 

Education and Experience Requirements

• M.D. or M.D./Ph.D. or equivalent qualification
• Minimum of 1-2 years of pharma/biotech industry experience or a recognized expert (assistant professor or equivalent) in the field of rare diseases (specifically lysosomal storage disorders)  with relevant clinical, scientific and clinical trial development experience
• Experience of Phase I – II drug development and execution, specifically experience in desi