WHY SPUR?
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.
WHAT WE ARE TRYING TO ACCOMPLISH
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. We are working on additional programs in research, with a focus on CNS and cardiovascular diseases, to reach even more patients with our potentially life-changing treatments. Spur is global, with research facilities and offices in Stevenage, UK, and offices in Boston and New York.
HOW WILL WE DO IT
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. We also know we can only achieve these things together, so we act as one Spur and expect that of each colleague in the company. We always do the right thing – the trust of patients and their caregivers is critical to our success. If you have an entrepreneurial mindset, are willing to work hard to transform the lives of patients, and share our values, then Spur could be the place for you.
ROLE PURPOSE
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. The position requires being comfortable in both the pre-IND as well as the ongoing trial setting.
Our GBA-Parkinson’s Disease program is rapidly moving through the IND-enabling research and development stages. 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. Spur’s PD program springboards off our work in Gaucher Disease, the lysosomal storage disorder caused by mutations in the GBA gene, resulting in deficiency of the resultant enzyme. 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. The development candidate utilizes these enhanced properties in the transgene and is paired with a CNS appropriate vector and codon optimization. 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. AMN is a devastating, progressive, neurodegenerative disease with no disease modifying treatments currently available. 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. Spur’s GBA-PD Research team works predominantly out of the UK, while the AMN Clinical team works predominantly out of the US. 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. This position reports to the VP, Head of Clinical Development.
ROLE AND RESPONSIBILITIES
- Clinical lead for the Parkinson’s Disease (PD) and Adrenomyeloneuropathy (AMN) programs
- Lead the Clinical Development Teams for each program
- 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
- Partner with members of the cross-functional team to develop clinical development plans that define the path for approval and registration
- 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
QUALIFICATION, EDUCATION AND EXPERIENCE REQUIREMENTS
- MD with knowledge of neurological diseases
- Minimum of 5 years of direct pharmaceutical drug development experience; must include experience of management of patients in a Phase 2-3 clinical trial
- Experience in neurological biopharmaceuticals highly desired; experience in PD, AMN, or other neurodegenerative diseases a plus
- 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
PREFERRED SKILLS
- Ability to plan, coordinate, and lead activities simultaneously on multiple projects
- Ability to work in a matrix and interact effectively with all levels of seniority, both internally and externally
- Demonstrate flexibility in a dynamic environment found in smaller biotech companies
- Ability to drive toward goals
- Strong organizational and strategic planning skills
- Transparent interpersonal interactions and inspirational leadership
- Excellent communication and presentation skills
