Vice President - Plainsboro, United States - Novo Nordisk US

Description

About the Department

The East Coast Hub is the next stage of our Global Development ambitions within the US. Within the Global Development organization this is a key new role to lead the Clinical Operations function across our Boston, MA and Princeton, NJ campuses through both direct leadership of the core Clinical Operations function, as well as ensuring close collaboration with other areas of Global Development and US Clinical, Medical and Regulatory (CMR). Your skills, dedication and ambition will help us change lives for the better. In exchange, we'll offer you an opportunity to work with extraordinary talent, continuously learn and develop, and drive change to defeat serious chronic conditions. We are changing lives, are you ready to make a difference?

The Position

This leadership position is accountable for resourcing, development, training and management of a highly performing Clinical Operations team. The position will provide strategic direction for, and executive oversight of, Clinical Operations matters relating to the project portfolio anchored within the East Coast Hub, including trial planning, study / protocol design and development, execution within budget and timelines, quality and compliance.

Relationships

This position reports to the Corporate Vice President (CVP) of Clinical Operations for CKAD and Rare Disease.

Essential Functions

• Provide strategic and operational guidance to ensure that trials are properly defined, planned, and executed across all clinical stage programs
• Managing the overall Clinical Operations strategy, direction and people development, by actively driving innovation and taking a broader and joint responsibility for clinical drug development across projects
• Establish, implement, and proactively manage clinical trial processes, strategic outsourcing and performance indicators
• In collaboration with other Vice Presidents of Clinical Operations in other global locations and therapy areas, proactively leads the optimisation of processes and drives the architecture and future operating model for Clinical Operations
• Is accountable for driving an engaging culture in accordance with Novo Nordisk Way and for inspiring and motivating employees and teams through empowerment and by enabling judgement-based decision and agility
• Is responsible for assuring compliance with the Novo Nordisk Quality system for Clinical Operations deliverables
• Provide continuous assessment and alignment of the clinical operations functions to ensure efficiency, effectiveness, and quality-by-design in operational execution; accountable for maintaining pro-active approach to inspection readiness
• Is overall responsible for the Clinical Operations LoB budget
• Is overall accountable for ensuring optimal resource utilization within the area/development portfolio at all times
• Is responsible for providing feedback regarding resource constraints and progress on defined deliverables to relevant stakeholders
• Drive talent and succession management, identifying high potentials and creates an environment where a learning culture is in focus to support individual and organizational learnings and development
• Contribute actively to the Organisational Development Plan (ODP)
• Is a member of the CVP CKAD and Rare Disease Clinical Operations Leadership Team - including actively contributing to the leadership and future development of the area
• Oversee and trouble-shoot clinical development program challenges, processes, activities and risk mitigation strategies pertaining to the conduct of clinical trials and key milestone deliverables, with direct reports/functional leads
• Oversee and provide relationship management support for external vendors and clinical partners to ensure delivery of clinical objectives within established timelines and budget
• Senior contributor for business development activities providing clinical expertise and strategic operational considerations
• Clinical representative of executive teams including, the Quality Counsel, Executive Safety Committee, GxP Risk Management Team, applicable CRO/vendor governance and due diligence teams
• Is a member of the Head Quarter Trial Management Council (HQTM Council)
• Is sponsor/Steering Committee (StC) member of Global Trial Portfolio (GTP) improvement projects and initiatives as applicable
• Supports and enables knowledge sharing and capability building across teams, projects and skill areas
• Drives innovation in clinical drug development, not only within own area but taking a broad and joint responsibility across projects, e.g., via working groups, cross-project collaboration and HQTM Council initiatives
• Lead by example; provide advisory support to colleagues and foster collaborative decision-making and achievement of corporate goals
• Communicate regularly and effectively with senior leaders across the R&D organization
• Perform other duties as required and assigned by supervisor

Physical Requirements

Approximately 30% overnight domestic and/or international travel, as needed. Ability to lift lbs.

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

• Bachelors, Masters or Doctorate degree in a life-sciences discipline with 15+ years progressive experience in clinical drug/device development working in a project oriented international matrix organization, including 5+ years of Clinical Operations line management experience
• Domestic and international clinical trial execution experience required
• Post-approval clinical management experience a plus
• Direct management experience over clinically related functions and experience working in a matrix environment with other functional groups (eg. Regulatory, Medical Writing, Med Affairs, Commercial)
• In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Experience in complex, rare and/or pediatric diseases, preferred
• Ability to manage early phase clinical programs up through to regulatory filing
• Demonstrated track record of successfully developing and executing on clinical development plans
• Proven ability to build strong relationships with external partners, CROs, and vendors including experience managing contracts and clinical finance activities
• Proficient at creating and communicating a clear vision among team members, effectively aligning resources and activities to achieve functional area and/or organization goals
• Analytical thinker with excellent problem-solving skills
• Excellent verbal and written communication skills
• Excellent planning, organization, and project management skills
• Flexibility to travel domestically and internationally, as required
• Proficiency with Excel and Microsoft Project
• English is the predominant language for most regulatory documents handled by this position; should be able to demonstrate good verbal and written English

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 [redacted]. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.