What are the responsibilities and job description for the Senior Director, Clinical Operations - Operational Excellence and Delivery position at BioSpace?
About The Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare 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?
The Position
Provides strategic vision, expertise, leadership and direction for own function as well as significantly contributing to the strategic planning for Clinical Development Operations (CDO) and the overall CMR function (e.g., provision of trial planning/implementation expertise, health equity initiatives and business development activities). Responsible for the strategic & tactical leadership of the OE function across the USA, including aspects relevant to resource planning (workload/capacity management), health equity initiatives and process improvement initiatives. Responsible for driving innovation to assure that effective risk & mitigation planning occurs in the early planning & ongoing governance of each clinical trial conducted by CDO based on trend reports and other relevant data. Responsible for establishing & growing internal & external partnerships relevant to the continuous improvement of clinical trial planning, placement and governance. Represents CDO and the broader CMR organization at conferences & global meetings.
Relationships
The position is a member of the USO CDO Leadership Team (LT) and reports directly to the Associate Vice President of CDO. The position is responsible for securing and maintaining strong cross functional relationships within CMR/NNI/HQ-GTP, across senior levels of the global Novo Nordisk organization & with senior members from academic, heath care and vendor organizations deployed for CDO. Works with all departments and internal NN stakeholders to ensure multi-disciplinary teams engage in effective strategic and tactical planning for every clinical trial to be considered and/or placed in the USA. Position is expected to be able to build/evolve relationships with leading academic/health professionals and operate as a senior ambassador for NN, our research products and our industry.
Essential Functions
Strategic Oversight:Drives clinical strategy development incl strategy for partnerships with key vendors
Accountable for strategic alignment of Health Equity initiatives across CMR and NNI to continuously enhance Clinical Trial participant access, diversity, inclusion
Provides direction to the OE function as well as CDO/CMR management on matters concerning trial planning, placement, resources, and site partnerships
Represents CDO at internal/external senior forums on strategic/tactical matters related to trial planning, placement & partnerships
Accountable for strategy, direction, timelines and effective resource deployment across the function.
Evaluates and communicates the probability and impact of portfolio risks and develops risk management plans for the overall function
Responsible for overall functional budget, including expense management and contract management
Maintains and builds knowledge of industry trends and developments to innovate and promote future strategic direction for clinical programs, studies, vendors, systems, and sites
In partnership with Medical Affairs, supports development of KOL plans and engagements, and leverages KOL input in context of development programs and communicating evidence
Leadership:Leads teams to assure compliance with policies, procedures, and fundamentals that drive effective trial planning, placement & governance in accordance with applicable laws and guidelines
Drives to assure balanced perspectives/progress against strategic priorities of function and negotiates the needs of multiple customers and stakeholders, effectively resolving problems and facilitating escalation as needed
Leads local and global senior management team initiatives in relation to improving the ways in which clinical trials are planned & implemented
Inclusively collaborates and problem solves across NN with an enterprise mindset; by building trust and driving toward the collective success of clinical program(s). Gathers diverse perspectives assess alternate resolutions and makes thoughtful, informed Enterprise decisions
Holds Oneself and Others Accountable: Takes initiative to address challenges, removes barriers, holds others accountable for the collective success of the program outcomes and team collaboration
As a senior member of staff, is expected to deputize for the AVP of CDO and may be assigned other duties and/or special projects as assigned by the Associate Vice President and the Group Vice President of CMR
Management:
Accountable For Delivery Of The Productivity Metrics For The Function And Ensures Evidenced-based Strategic Recommendations Related To Feasibility ActivitiesActs Rapidly, Appropriately, Decisively And Consistently In Cases Of Observed Or Reported Potential Policy ViolationsProactively Assesses Performance Of Direct Reports And Helps Guide In Their Continued DevelopmentCreate a Performance-based Team Culture With Clear Accountability And a Sense Of Urgency For Achieving ResultsBusiness Development
Accountable for CDO business development activities, including mergers and acquisitions
Lead interactions with clinical investigators, academic organizations, co-development partners, and strategic outsourcing/procurement
Physical Requirements
10-20% 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
A Bachelors degree required (in science-related discipline preferred); advanced degree preferred
A minimum of 15 years progressively increasing & relevant experience in drug and/or device development; previous experience in the pharmaceutical, biotechnology and/or CRO industry is preferred
A minimum of 5 years supervisory experience required, with global supervisory experience preferred
Demonstrated experience with international GCP and core expertise with relation to the FDA and other health authority interactions
Strong senior leadership presence, analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from international representation at a senior management level
Demonstrated computer skills (MS Office, MS Project, and MS PowerPoint)
The base compensation range for this position is $229,200 to $401,100. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare 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?
The Position
Provides strategic vision, expertise, leadership and direction for own function as well as significantly contributing to the strategic planning for Clinical Development Operations (CDO) and the overall CMR function (e.g., provision of trial planning/implementation expertise, health equity initiatives and business development activities). Responsible for the strategic & tactical leadership of the OE function across the USA, including aspects relevant to resource planning (workload/capacity management), health equity initiatives and process improvement initiatives. Responsible for driving innovation to assure that effective risk & mitigation planning occurs in the early planning & ongoing governance of each clinical trial conducted by CDO based on trend reports and other relevant data. Responsible for establishing & growing internal & external partnerships relevant to the continuous improvement of clinical trial planning, placement and governance. Represents CDO and the broader CMR organization at conferences & global meetings.
Relationships
The position is a member of the USO CDO Leadership Team (LT) and reports directly to the Associate Vice President of CDO. The position is responsible for securing and maintaining strong cross functional relationships within CMR/NNI/HQ-GTP, across senior levels of the global Novo Nordisk organization & with senior members from academic, heath care and vendor organizations deployed for CDO. Works with all departments and internal NN stakeholders to ensure multi-disciplinary teams engage in effective strategic and tactical planning for every clinical trial to be considered and/or placed in the USA. Position is expected to be able to build/evolve relationships with leading academic/health professionals and operate as a senior ambassador for NN, our research products and our industry.
Essential Functions
Strategic Oversight:Drives clinical strategy development incl strategy for partnerships with key vendors
Accountable for strategic alignment of Health Equity initiatives across CMR and NNI to continuously enhance Clinical Trial participant access, diversity, inclusion
Provides direction to the OE function as well as CDO/CMR management on matters concerning trial planning, placement, resources, and site partnerships
Represents CDO at internal/external senior forums on strategic/tactical matters related to trial planning, placement & partnerships
Accountable for strategy, direction, timelines and effective resource deployment across the function.
Evaluates and communicates the probability and impact of portfolio risks and develops risk management plans for the overall function
Responsible for overall functional budget, including expense management and contract management
Maintains and builds knowledge of industry trends and developments to innovate and promote future strategic direction for clinical programs, studies, vendors, systems, and sites
In partnership with Medical Affairs, supports development of KOL plans and engagements, and leverages KOL input in context of development programs and communicating evidence
Leadership:Leads teams to assure compliance with policies, procedures, and fundamentals that drive effective trial planning, placement & governance in accordance with applicable laws and guidelines
Drives to assure balanced perspectives/progress against strategic priorities of function and negotiates the needs of multiple customers and stakeholders, effectively resolving problems and facilitating escalation as needed
Leads local and global senior management team initiatives in relation to improving the ways in which clinical trials are planned & implemented
Inclusively collaborates and problem solves across NN with an enterprise mindset; by building trust and driving toward the collective success of clinical program(s). Gathers diverse perspectives assess alternate resolutions and makes thoughtful, informed Enterprise decisions
Holds Oneself and Others Accountable: Takes initiative to address challenges, removes barriers, holds others accountable for the collective success of the program outcomes and team collaboration
As a senior member of staff, is expected to deputize for the AVP of CDO and may be assigned other duties and/or special projects as assigned by the Associate Vice President and the Group Vice President of CMR
Management:
Accountable For Delivery Of The Productivity Metrics For The Function And Ensures Evidenced-based Strategic Recommendations Related To Feasibility ActivitiesActs Rapidly, Appropriately, Decisively And Consistently In Cases Of Observed Or Reported Potential Policy ViolationsProactively Assesses Performance Of Direct Reports And Helps Guide In Their Continued DevelopmentCreate a Performance-based Team Culture With Clear Accountability And a Sense Of Urgency For Achieving ResultsBusiness Development
Accountable for CDO business development activities, including mergers and acquisitions
Lead interactions with clinical investigators, academic organizations, co-development partners, and strategic outsourcing/procurement
Physical Requirements
10-20% 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
A Bachelors degree required (in science-related discipline preferred); advanced degree preferred
A minimum of 15 years progressively increasing & relevant experience in drug and/or device development; previous experience in the pharmaceutical, biotechnology and/or CRO industry is preferred
A minimum of 5 years supervisory experience required, with global supervisory experience preferred
Demonstrated experience with international GCP and core expertise with relation to the FDA and other health authority interactions
Strong senior leadership presence, analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from international representation at a senior management level
Demonstrated computer skills (MS Office, MS Project, and MS PowerPoint)
The base compensation range for this position is $229,200 to $401,100. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
Salary : $229,200 - $401,100