About the Department
The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference?
We are looking to hire a Senior Clinical Project Manager (CPM). 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. The Senior CPM will be responsible for all aspects of clinical trial management aimed at treating a rare or infectious liver-targeted disease. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.
Reports to: Director of Clinical Operations. Supervises junior staff such as Clinical Trial Associates.
- 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 Program 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 Dicerna 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
0-10% overnight travel required.
Development of People
Supervisory, 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.
- Bachelor’s degree in a scientific discipline is required
- Minimum of 8 years of clinical development experience in the pharmaceutical industry
- At least 3-5 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
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.