Job Description

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 \xe2\x80\x93 until now.

We don\xe2\x80\x99t follow footsteps. We create the path.

Primary Duties

The Medical Lead 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 Medical Lead 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 programmes. This includes being responsible for the preparation and review of relevant components of study related documents such as Protocols, Investigator\xe2\x80\x99s 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)
• Analysing 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.

Education and Experience Requirements

• Board-certified M.D. or M.D./Ph.D. or equivalent qualification with relevant medical experience is required
• 3 or more years pharma/biotech industry experience OR is a recognized expert in the field of rare diseases, specifically lysosomal storage disorders is preferred
• Experience of Phase I \xe2\x80\x93 II drug development and execution is required. An appreciation for Phase III-IV drug development would be beneficial
• Multidisciplinary experience in the pharma/biotech industry is strongly preferred (e.g., research, regulatory, clinical operations, business development, commercial operations, etc.)
• Broad experience in the principles and techniques of data analysis and, interpretation
• Experience publishing results of interventional clinical trials in peer-reviewed journals is an advantage
• Experience managing or leading teams is preferred
• Academic/teaching background is preferred
• Working 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 is expected.
• Global travel required (approximately 30%)

Key Skills, Abilities, and Competencies:

• Strong knowledge of the drug development and approval process and clinical trial design
• Strong communication skills (written and oral); excellent presentation skills required, as well as strong interpersonal and leadership skills
• Capable of representing Spark professionally with external global opinion leaders, 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 more junior staff about clinical and strategic issues
• Ability to stay abreast of internal and external developments, trends and other dynamics relevant to the work of Clinical Development 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

Complexity and Problem Solving

• Self-motivated and detail-oriented with the ability to prioritize and handle multiple projects simultaneously
• Ability to plan and think strategically and critically
• Ability to critically evaluate scientific literature and clinical trial data

Internal and External Contacts

This role will interact on a regular basis with a variety of internal and external colleagues, including (but not limited to): other internal clinical, non-clinical, regulatory, medical, safety, R&D, and commercial personnel, external vendors (CROs, labs), investigators and investigative sites, consultants, global key opinion leaders, and global regulators.

#LI-Hybrid

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.

Spark Therapeutics