Responsibilities include: Accountable for the oversight and execution of multiple clinical trials including: Develop, implement, and provide oversight of vendor budgets and contracts Tracking and reporting of study metrics Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion Develop and manage effective working relationships with Investigators and other key clinical opinion leaders Provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct Remains current with therapeutic areas under study, industry practices / trends and FDA requirements. Applies this knowledge to current programs Partners with and maintains regular contact with key stakeholders including Regulatory, Clinical Development, Legal, Finance, and others as necessary Leads the team in the selection of Contract Research Organizations (CROs) for both large budget and small budget Attends CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals Contributes to definition, development, and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices Travel may be required up to 30% in support of clinical study activities

Education, Experience, and Skills:

Required:

BS/BA degree in related discipline or equivalent combination of education and experience 10+ years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in ophthalmology, neurology, rare diseases, and overall drug development. Strong leadership skills with ability to be hands-on and lead/ manage the clinical team. Experience with direct line-management of clinical operations staff. Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines Has demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors Experience with financial budgeting or reporting Ability to interact with investigators, vendors, and individuals at all levels of the organization Base $175-200K based on experience level