Location: Philadelphia, PA
Company: Spark Therapeutics
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 Sub Team (Dev ST), 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 designing and conducting clinical trials, 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 medicals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations is expected.
Key Skills, Abilities, and Competencies 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 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 Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.
The base salary range for this position is currently from $157,900 to $236,900. #LI-Hybrid 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.
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