Medical Director
2 days ago
Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians and other professionals who are singularly focused on using cutting-edge science and technology to transform the treatment of serious and debilitating chronic diseases.
We are a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, Spur is focused on developing innovative, one-time treatments that set new standards of care. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering and clinical development, and we optimize every component of our product candidates to develop first- and best-in-class gene therapies. We are currently advancing a highly differentiated gene therapy candidate in a Phase 1/2 clinical trial in people with Gaucher disease. Spur is global, with research facilities and offices in Stevenage, UK, and offices in Boston and New York.
We are relentless in our pursuit of transformative medicines for patients. We take innovation seriously and know we need to be bold both in our science and in every aspect of our work. Spur is looking for a highly motivated and energetic Senior Medical Director to lead two major neurology development programs at different stages of their lifecycle. We are seeking a collaborative development medical director that will work alongside the Research, Clinical, and Regulatory teams, as well as with external partners, to establish a robust strategy that bridges research plans and activities through to a first-in-human study. Approximately 5–15% of PD patients have mutations in the GBA gene, making it the most important genetic risk factor for PD. This program is currently in clinical trials. Spur’s proprietary, protein-engineered GCase85 molecule, utilized in our ongoing Gaucher clinical trial, demonstrates continued expression out past 1 year of infusion with a favorable benefit:risk profile to date, suggesting a potential carryover of these benefits to the GBA-PD program. Therefore, the Medical Director on the GBA-PD program will need to be conversant in the data set emerging from the Gaucher program and work closely with that team.
Our adrenomyeloneuropathy (AMN) program is actively in clinical trials with multiple patients already dosed. This program requires a Medical Director excited to take on the activities associated with an ongoing clinical trial in a rare disease including medical monitoring, considerations for the regulatory approach, data analysis, and patient organization interactions.
The candidate is a team player, interested in working not only across functional areas within the Neurology programs, but also in collaboration and alignment with the broad Clinical Development team of our other programs. Therefore, this candidate needs to be comfortable with the dynamic of remote integration of at least one of the programs.
This is a hybrid role located in Stevenage, UK or Boston, MA. Serve as the medical expert for the PD and AMN study teams
Serve as a key member of the GBA-PD team, participating in nonclinical data reviews and interpretation, assessment of potential biomarkers, and considerations for desired nonclinical outcome measurements that could help drive the clinical program
Design, execute, and provide oversight of clinical trials as well as in their interpretation
Drive the execution of the clinical program including, but not limited to the development of study protocols and Investigator Brochures, data review and analysis, review of monitoring plans, SAPs and study start up activities
Lead the safety review and management of patients actively being treated in clinical programs
Work closely with CROs on patient management, safety oversight, and site interactions
Contribute and participate in activities to support regulatory submissions, including authoring clinical sections for INDs, NDAs, CSRs and other related documents
Establish high-level relationships with global key opinion leaders as well as with key external decision-makers, like FDA/EMA and other regulatory bodies, as well as patient advocacy groups
Present emerging data at medical conferences and to various external stakeholders
Set the agenda and lead advisory boards, investigator meetings, Data Monitoring Committee (DMC) external medical strategy forums, and other key internal and external focus meetings as necessary
Provide medical information and insights on existing and emerging data within the field of PD and AMN
Interact closely with other groups within the company including Regulatory Affairs, Clinical Operations, external CROs, Program team, Biostatistics, PV, and Research
Identify program, trial or data risks, creating and implementing mitigation strategies
Contribute to authoring of annual reports, regulatory updates, clinical study reports
Ensure compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
Minimum of 5 years of direct pharmaceutical drug development experience; must include experience of management of patients in a Phase 2-3 clinical trial
Appreciation for translational development and ability to work closely with the Research team to drive a robust development path for an IND-enabling stage asset
Substantial experience in designing and executing clinical studies
Experience in the development of gene therapy medicinal products or rare disease products a plus
Experience in interaction with Regulatory Authorities
A demonstrated ability to create and drive an effective medical strategy
Ability to plan, coordinate, and lead activities simultaneously on multiple projects
Strong organizational and strategic planning skills
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