Job Title

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 by optimizing 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 into a Phase 3 clinical trial in people with Gaucher disease and a preclinical gene therapy program for Parkinson’s disease. Spur is global, with offices in Stevenage, UK, as well as operations 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 The Associate Director is in a key position as the medical monitor of the Gaucher clinical trials. These trials include the registrational Phase 3 trial and the ongoing long-term follow trial from the first-in-human Phase 1/2 program. The candidate is someone excited to dive further into the role of medical monitor in a registrational trial. Having had some experience in clinical trial medical oversight (e.g., early Phase clinical trial medical monitoring, CRO medical monitoring, significant academic trial involvement) this position is ideal for someone who wants to take the next step in their career. As the lead medical monitor for this highly visible, Phase 3, registrational trial, the AD will bring:Sharp medical acumen Comfort in being the first line of medical responsibility in an investigational trial setting Ability to see how the details fit into the larger picture of the possible benefits and risks of the investigational product and, subsequently, into the goals of the company Ability to “work backwards”- based on the desired outcome of the trial, determine how to get the answers in a safe, rapid, and compliant fashion General understanding of the complexities of trial execution including the need for high levels of clinical compliance to regulatory and legal statutes Strong communication skills, allowing for the clear and concise delivery of medical findings to non-medical colleagues Desire to learn broader aspects of Clinical Development including regulatory, pharmacovigilance, and Clinical OperationsThis position reports to the Head of Clinical Development. Role and ResponsibilitiesMedical monitor for the Gaucher program (Phase 3 trial, and Phase 1/2 long-term follow up trial) Continuous review of safety parameters of all treated participants Continuous review of safety trends in emerging datasets; alignment with Head of Clinical Development Understanding of emerging literature of other AAV gene therapies and consideration for its relevance to the Gaucher programs if any Participation in safety update calls with the CRO medical teams Participation in the independent Data Safety Monitoring Board (DSMB) meetings Front line contact for all trial investigators to discuss patient medical eligibility and safety data as needed Participate in the execution of the Gaucher clinical trials, including site visits and training Interpret safety and efficacy datasets as they emerge in relation to desired outcomes and clinical relevance Partner with members of the Clinical Operations and Regulatory teams on site and Regulatory Authority responses as needed Develop materials for internal communication of data as appropriate Develop publication strategies including medical congress plans Participate in authoring and reviewing congress material for accuracy Attend medical conferences and congresses on behalf of Spur Participate in medical advisory boards including preparation of materials Review external materials for medical accuracy as part of MLR (Medical, Legal, Regulatory) team Partake in discussions with Patient Advocacy Groups Contribute to authoring of annual reports, regulatory updates, clinical study reports Keep abreast of latest trends and data in gene therapyQualification, Education and Experience RequirementsMD or equivalent Minimum of 2 years of medical monitoring experience within the US/EU/UK, specifically for an investigational product sponsored by a pharmaceutical company Experience in genetics or lysosomal storage diseases is desirable Experience in rare diseases a plus Experience in designing and/or executing clinical studiesPreferred SkillsThe ability to multitask on trial execution and data communication, while staying on top of all emerging safety data Excellent communication and presentation skills, particularly with external health care providers and internal non-medical colleagues Ability to prioritize workstreams based on simultaneous patient safety needs and corporate goals The ability to work in a matrix and interact effectively with all levels of seniority both internally and externally. Awareness that decisions and strategies within the Clinical Development and Corporate teams are derived from multiple inputs, in addition to medical insights Strong organizational skills Good interpersonal and leadership skills#J-18808-Ljbffr