What are the responsibilities and job description for the Sr. Medical Director, Genetic Medicine position at Spur Therapeutics?

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

Spur is a clinical-stage biotech company developing transformative gene therapies using adeno-associated virus (AAV) vectors. Founded in 2015, we focus on creating 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.

Our pipeline spans clinical, pre-clinical, and discovery-stage programs that could significantly improve the lives of patients with chronic and debilitating diseases. Current programs include :

FLT201 : A highly differentiated gene therapy candidate for Gaucher disease with a planned Phase 3 start in 2025.
SBT101 : A first-in-class treatment candidate for adrenomyleoneuropathy (AMN), currently in Phase 1 / 2.
SPR301 : A potential first-in-class treatment for GBA1 Parkinson’s Disease, entering IND-enabling studies in 2025.
We are also working on additional programs in research, with a focus on central nervous system (CNS) and cardiovascular diseases, to reach even more patients with our potentially life-changing treatments.

By advancing first- and best-in-class programs, we aim to extend the reach of gene therapy and deliver potentially life-changing treatments to more patients. Spur operates globally, with research facilities and offices in Stevenage, UK, and offices in Boston and New York City.

How We Will 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

This is a hybrid role, located in Stevenage, UK, Boston, or New York. This position reports to the Vice President, Head of Clinical Development. This is an exceptional opportunity for a driven, solutions-oriented clinical developer to make a significant impact on patients through genetic medicines while shaping the future of our company.

Role and Responsibilities

Clinical lead for the FLT201 (Gaucher disease) program moving into Phase 3 in 2025. In this role you will :

Drive design, execution, and oversight of the Phase 3 clinical trial. Responsibilities include, but are not limited to, the development of study protocols and investigator brochures, data review and analysis, review of monitoring and statistical analysis plans. You will have a key role supporting study start up activities such as site initiation visits, investigator meetings, etc.

Partner with members of the cross-functional team to develop clinical development plans that define the path for approval and registration. Collaborate closely with the technical operation (CMC) team to ensure workstreams alignment.

Contribute and participate in activities to support regulatory submissions, including authoring clinical sections for INDs, NDAs, annual reports, regulatory updates, clinical study reports.

Establish high-level relationships with global key opinion leaders as well as with key external stakeholders such as health authorities and patient advocacy groups.

Develop the agenda and lead advisory boards, investigator meetings, Data Monitoring Committees (DMC), and other key internal and external focus meetings.

Serve as the medical and scientific expert for internally and externally. Provide medical information and insights on existing and emerging data relevant to the program.

Contribute to activities related to market readiness, and potential future successful commercialization.

Ensure compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.

In addition to serving as the clinical lead for the FLT201 program, additional responsibilities for other programs may be assigned to you. These responsibilities may include, but are not limited to :

Acting as the clinical lead for additional programs.

Contribute to discussions on clinical development strategy, including the evaluation of new indications or subpopulations for development in other programs.

Serving as the medical or clinical development subject matter expert to support discovery and translational research initiatives.

Contributing to business development and partnership efforts.

Qualification, Education and Experience Requirements

M.D., M.D. / Ph.D. (or equivalent). A Ph.D. with demonstrated experience leading clinical stage program as a clinical scientist (with physician oversight) may be considered.

Minimum of five years of direct pharmaceutical drug development experience, which includes leading, designing and executing clinical studies.

Desirable experience includes :

Clinical development experience that includes late-stage Phase 3 trials and experience in interactions with health authorities.

Experience with gene therapy and / or virology.

Experience in rare disease (lysosomal storage disorders), neurology, neuroscience, and / or cardiology, either in a scientific or clinical capacity.

Required Skills

Proven ability to excel as both an individual contributor and a leader, consistently driving successful outcomes.

Collaborative team player with the capacity to lead and contribute effectively, ensuring successful execution of goals.

Ability to navigate a matrixed environment and collaborate effectively with stakeholders at all levels, both internally and externally.

Adaptable and comfortable thriving in a fast-paced, dynamic environment.

Exceptional written and verbal communication skills, with the ability to represent Spur externally and cultivate strong strategic partnerships.

Thrive in a high-ownership culture by demonstrating accountability, initiative, resourcefulness, and a proactive, hands-on approach.

Exhibit a learning mindset with flexibility, adaptability, and the ability to make sound decisions quickly.

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Sr. Medical Director, Genetic Medicine

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