The incumbent will drive integrated planning, continued process improvement and operational excellence to meet our growth objectives, including research and development strategic planning, resource planning, space planning and change management efforts to enable the smooth functioning
The candidate will be responsible for the development and implementation of high-impact strategic scientific publications, physician-directed communications, educational resources for field medical use, and medical education for identified Spark products, with a focus on Ophthalmology.
The Head of Regulatory CMC will be responsible for leading preparation of high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management.
Create, review, and maintain Medical Affairs scientific materials, including but not limited to standard and customized response documents, scientific slide decks, and clinical dossier/managed market documents in collaboration with MI Leads, Medical Affairs and other functional area colleagues.
The Supply Chain Lead is relied upon to maintain a holistic understanding of the demand and supply dynamics affecting Spark's US product portfolio. This strategic role combines aspects of product strategy, procurement, supply chain planning and logistics for clinical and commercial supply of novel gene therapies.
Identifies, establishes and maintains collaborative relationships with key experts, investigators and institutions strategic to Spark's scientific interests, particularly potential treatment centers of excellence for Spark investigational and/or approved products
Leads culture programs and solutions in alignment with Spark mission, vision and values including but not limited to integrating culture into the hiring, development, recognition and performance management process
Drives the direction and leadership of the PD downstream team. Leads set up of drug product quality profiles of rAAV-based products and to develop cost effective, operations, robust and fully scalable rAAV downstream purification processes, including drug product final vialing strategies
Lead and oversee the planning and development of PV risk management activities within SDEAs throughout product development, commercialization, and post-marketing commitments, and the development, implementation, revision and progress reports of risk management plans, as required by global health authorities. Develop aggregate report strategy and timelines with key stakeholders and vendor. Support RMP and REMS reports as appropriate.
S/he will responsible for identifying patients, identifying retinal specialist practices that have Inherited Retinal Dystrophy (IRD) patients, and identifying and developing Genetic Testing Key Opinion Leaders (KOLs) within the assigned region.