Associate Director - Clinical Operations

About the Department
Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development 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. We recognize that improving human health starts here and that patients rely on us. We're changing lives for a living. Are you ready to make a difference?
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 to late-stage clinical programs. The Associate Director role will be responsible for all aspects of clinical trial management and oversight of trial teams.
Relationships
This position reports to the Director, Clinical Operations.
Essential Functions

• Collaborate with internal stakeholders and oversee performance of internal affiliates, CROs, third party vendors, and contractor to ensure compliance with study protocol. Resolves or escalates major/cross-program issues, supported by Director of Clinical Operations
• Collaborate with the Clinical Trial Leads and study teams with lines of business to develop patient recruitment strategies, operational feasibility, and implementation of study objectives.
• Implement and use efficient project management tools, e.g., Communication Plan and Risk Based Quality Monitoring documents, such as Risk Assessment Categorization Tool (RACT)
• Ensure country and site selection meet study requirements.
• May review critical study documents, such as consent forms, study manuals, subject recruitment materials,
• Assist in trial governance stages gates and help teams prepare for governance interactions.
• Independently manage interactions with clinical leads, data management, safety, regulatory, 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 oversight for study level data review, including trend evaluation and full risk assessment.
• Provide input in internal/external study related audits, review resulting reports.
• Trial Operations in relevant fora/ working groups/ Steering committees (e.g. Medical & science Team, Improvement Projects, Core Teams)
• Adapts departmental plans and priorities to address resource and operational challenges
• Manages high complexity projects and drives efficient resource utilization with direct impact on SVP area results
• Role models, ensures, and encourages sharing better practice and consistency across Clinical Operations
• Contribute to keeping Clinical Operations in compliance with all existing applicable requirements and overall ensuring ICH GCP compliance for the clinical trial(s)
• The tasks will be performed independently, in agreement with the relevant Director of Trial Operations
• Proven subject matter expertise. Manages field of expertise that requires highly specialized knowledge of strategic importance to the SVP area
• The tasks will be executed according to SOPs, Novo Nordisk Policies and Novo Nordisk Way
• The Associate Director is expected to lead the Trial Squads, work with situational flexibility, fit-for-purpose application of strategy and with a deliverable-driven mindset
• The Associate Director should always model judgment- and information-based decision making
• The Associate Director will participate in different cross functional settings and is expected to identify, lead and drive process- and business improvement initiatives, also where solutions are not always evident
• The Associate Director understands the core competencies and skills in the function and the value chain of the company

Physical Requirements
20% overnight travel required.
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.