About the Department

　　Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources , and stability, uniting the best of both worlds to develop new medicines for patients.

　　The Position

　　We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in a growing Clinical Operations department that manages multiple early-stage clinical programs based on an innovative RNAi technology platform. This role will be responsible for all aspects of clinical trial management aimed at treating a rare liver-targeted disease. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.

　　Relationships

　　This position reports to the Director, Clinical Operations.

　　Essential Functions

　　Oversee performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating to Clinical Program Lead when appropriate

　　Collaborate with the Clinical Trial Lead and study team to develop patient recruitment strategies, operational feasibility and implementation of study objectives

　　Develop study plan(s) including key milestones and timelines

　　Ensure country and site selection meet study requirements

　　Participate in the development and testing of clinical systems (e.g., data capture, IxRS)

　　Ensure internal and external systems are updated in a timely manner (e.g., trackers, clinicaltrials.gov)

　　Manage critical study documents, such as consent forms, study manuals, subject recruitment materials

　　Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF

　　Drive critical clinical trial activities including trial site activations, recruitment, and database lock

　　Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting

　　Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally

　　Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points

　　Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation

　　Provide input in internal/external study related audits, review resulting reports

　　Review monitoring reports and, if applicable, corrective action plans at individual sites and provide oversight to ensure safety concerns are identified and responses developed

　　Communicate trial status, issues, and mitigations to relevant cross-functional stakeholders

　　Represent Novo Nordisk during site initiation visits, trainings, close out visits, and conduct co-monitoring visits as needed

　　Train study team members, external monitors, and site staff as needed

　　Physical Requirements

　　10-20% overnight travel required.

　　Development of People

　　Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

　　Qualifications

　　Bachelor’s degree is required; in a scientific discipline is preferred

　　Minimum of 8 years of clinical development experience in the pharmaceutical industry with management experience

　　At least 5 years of experience as a Clinical Trial Manager

　　Experience with global clinical trial operations, in multiple phases of research

　　Strong knowledge of ICH guidelines, GCP and FDA regulations

　　Experience with all aspects of trial and site startup and vendor management

　　Experience in rare disease, pediatric, and/or complex clinical trials preferred

　　Ability to deal with multiple priorities with aggressive timelines

　　Strong oral and written communication skills

　　Ability to find creative solutions to issues impacting timelines and budgets

　　Willingness to travel domestically and internationally

　　We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

　　At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

　　Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

　　If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.