Novo Nordisk Inc Hiring for Therapy Area Head – North America Clinical Trial Operations job in Plainsboro Full Time

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

Multiple positions available.

The Position

The Therapy Area (TA) head in North America Clinical Development (NACD) is accountable for execution of all Novo Nordisk trial programs within the relevant therapy area. They are responsible for leading the therapy area units (TA units) like independent and empowered business units with “one voice/ one vision, drive key business goals within the therapy area, and act with a sense of urgency and agility in response to business needs.

Relationships

The position reports into VP, NACD and will have all relevant in-house and field functions required to run the TA units reporting into them, e.g., program directors, field directors, clinical project leads and clinical site leads. They will also be the senior strategic representative of NACD for the relevant therapy area in Global Project Teams (GPTs), Evidence Generation Planning (EGP) team, and will be the point of contact for the relevant Global CPVP functions. As part of NACD Senior Leadership Team they will be working together with the VP NACD to set the vision and strategy for the NACD organization.

Essential Functions

• Deliver overall vision and strategy for the TA unit in consultation with TA leadership team
• Responsible for execution of all operational aspects of Novo Nordisk trial programs within the relevant therapy area
• As a senior level representative of NACD, the TA head will work closely with the relevant global CDD s leadership teams to ensure that operational priorities are aligned
• Responsible for representing her/his organization to the relevant enterprise and global teams
• Conduct regular business planning for her/his organization, looking at structure, process, people, skills and capabilities. They should also continuously benchmark their organizations against external competition to ensure that we stay competitive as a clinical operations organization. The TA head will be expected to have a 3-5 years business plan for the TA unit.
• Ensure that they create a high performing TA unit leadership team that is focused, empowered, delivers on current business priorities but is also planning for the future
• Ensure that the unit delivers to targets, and also exhibits transparency and proactive communicates potential challenges to clinical trial programs within the TA
• Drive a culture of patient focus, inclusiveness, respect, curiosity, entrepreneurism and role model the Novo Nordisk way
• Related to audits and inspection, the TA head is overall responsible for development and execution of corrective and preventive actions associated with the planning, placement, execution and governance of clinical trials in North America
• Related to Quality, the TA head is overall responsible for contributing as an LT member to the Quality Management Review (QMR) in NNI and NNCI and following up on all actions relevant to the TA
• As a core member of the NACD Leadership Team, the TA head will ensure that the NACD organization has a comprehensive plan for the future, is aligned and coordinated in its approach on cross TA issues and is role modeling the Novo Nordisk way of working
• Responsible for ensuring that the Project Directors are running the field teams efficiently and in accordance with compliance practices
• Review and audit direct report expense reports. Manage direct reports in the tracking of budgets and expenditures. Ultimately responsible for managing the budget actual spend versus LE by status reports, meetings, and influence of other members
• Together with TA head in Medical Affairs, drive initiatives to support trial/study investigation sites; ensuring effective coordination and facilitation of studies to ensure timely review, initiation, and completion, as well as publication of study results
• Coach and develop direct reports to be strategic leaders, proactively assesses performance of direct reports and helps guide in their continued development

Physical Requirements

20-30% 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.

Qualifications

• An advanced Health degree required, M.D., PharmD. Preferred
• Minimum of 10 years progressive pharmaceutical industry experience required
• Minimum of 5 years previous clinical operations experience required
• Minimum of 5 years of people management experience required
• Proven track record of success, especially in the area of establishing relationships with opinion leaders and in team management

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.