Medical Director, Neurology - Boston, United States - Freeline Therapeutics

Description

• Generous holiday allowance
• Life assurance
• Gym membership
• Medical cover
• Pension
• Shower at work
• Sport clubs
• GP consults
• 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 cuttingedge science and technology to transform the treatment of serious and debilitating chronic diseases.
• What We Are Trying to Accomplish
• 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
• 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 crossfunctional 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 highlevel relationships with global key opinion leaders as well as with key external decisionmakers, 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

• 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