Why Freeline?
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 Freeline'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, Freeline 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. Freeline is global, with research facilities and offices in Stevenage, UK, and offices in Boston and New York.
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 Freeline 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 Freeline could be the place for you.
Role Purpose
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.
Responsibilities

• Clinical lead for the Adrenomyeloneuropathy (AMN) program and for the Parkinson's Disease (PD) program.
• Participate in the design, execution, and 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
• 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
• 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 AMN and Parkinson's Disease, including that of potential competitors
• Lead the Clinical Development Team
• Serve as the medical expert for the AMN and PD study team
• 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

Qualifications & Experience Required

• MD or equivalent with knowledge in Neurologic diseases
• Minimum of 6 years of direct pharmaceutical drug development experience
• Experience in AMN and/or PD a desirable plus
• 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 and Payers
• A demonstrated ability to create and drive an effective medical strategy
• 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.
• Ability to drive themselves towards goals
• Organizational and strategic planning
• Transparent interpersonal interactions and inspirational leadership
• Excellent communication and presentation skills
• Apply Now