Senior Director, Clinical Operations - Operational Excellence and Delivery
$229.2k - $401.1kNovo Nordisk A/S
Senior Director, Clinical Operations - Operational Excellence and Delivery Facility: Business Support & Administration Location: Plainsboro, NJ, US 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. You will help patients around the world and innovate ways to improve their quality of life. The Position Provides strategic vision, expertise, leadership and direction for the OE function and contributes to the strategic planning for Clinical Development Operations (CDO) and the overall CMR function. Responsibilities include trial planning and implementation expertise, health equity initiatives and business development activities, resource and capacity planning across the USA, risk and mitigation planning, partnership development, and representing CDO and CMR at conferences and global meetings. Relationships The position is a member of the USO CDO Leadership Team and reports directly to the Associate Vice President of CDO. It builds strong cross‑functional relationships within CMR/NNI/HQ‑GTP, senior levels of the global Novo Nordisk organization, and senior members from academic, health‑care and vendor organizations deployed for CDO. It works with all departments and internal stakeholders to engage multidisciplinary teams in effective strategic and tactical planning for every clinical trial in the USA. Essential Functions Strategic Oversight: Drive clinical strategy development, including strategy for partnerships with key vendors. Align Health Equity initiatives across CMR and NNI to enhance clinical trial participant access, diversity, and inclusion. Provide direction to the OE function and CDO/CMR management on trial planning, placement, resources, and site partnerships. Represent CDO at internal and external senior forums on strategic and tactical matters related to trial planning, placement, and partnerships. Accountable for strategy, direction, timelines, and effective resource deployment across the function. Evaluate and communicate portfolio risks and develop risk‑management plans for the overall function. Responsible for the overall functional budget, including expense and contract management. Maintain and build knowledge of industry trends to innovate and promote future strategic direction for clinical programs, vendors, systems, and sites. In partnership with Medical Affairs, support development of KOL plans and engagements and leverage KOL input in development programs and evidence communication. Leadership: Lead teams to ensure compliance with policies and fundamental practices for effective trial planning and governance. Ensure balanced progress against strategic priorities of the function and negotiate needs of multiple stakeholders, resolving problems and escalating as needed. Lead local and global senior management initiatives to improve planning and implementation of clinical trials. Collaborate across Novo Nordisk with an enterprise mindset, building trust and driving collective success of programming. Hold oneself and others accountable, removing barriers and fostering a culture of performance and urgency. As a senior staff member, deputize for the AVP of CDO and may be assigned other duties or special projects by the Associate Vice President or the Group Vice President of CMR. Management: Accountable for productivity metrics and provide evidence‑based strategic recommendations related to feasibility activities. Act decisively and consistently in response to potential policy violations. Proactively assess performance of direct reports and guide their development. Create a performance‑based team culture with clear accountability and urgency for results. Business Development: Accountable for CDO business development activities, including mergers and acquisitions. Lead interactions with clinical investigators, academic organizations, co‑development partners, and strategic outsourcing or procurement. Development of People Supervisory responsibilities include ensuring reporting personnel have individual development plans (IDP) with annual goals, consistent with business priorities. IDP forms contain completed learning and aspiration plans and are maintained for all reporting personnel. The manager also communicates and implements Novo Nordisk policies, procedures, and corporate culture. Qualifications BA/BS in a science‑related discipline required; advanced degree preferred. At least 15 years of progressively increasing and relevant experience in drug and/or device development; prior experience in the pharmaceutical, biotechnology, or CRO industry preferred. Minimum 5 years of supervisory experience required; global supervisory experience preferred. Demonstrated experience with international GCP, FDA interactions, and other health authority engagements. Strong senior leadership presence and skills in analytics, negotiation, meeting management, cross‑functional collaboration, and senior‑level representation. Proficient computer skills (MS Office, MS Project, MS PowerPoint). Compensation & Benefits The base compensation range for this position is $229,200 to $401,100, determined by experience and performance. The role is eligible for a company bonus, long‑term incentive compensation, company vehicles, and various benefits including medical, dental, vision, life insurance, disability insurance, 401(k), flexible spending accounts, employee assistance program, tuition reimbursement, and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance. Flexible vacation and parental leave policies apply as per company guidelines. Equal Opportunity We commit to an inclusive recruitment process and equality of opportunity for all applicants. 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. #J-18808-Ljbffr Novo Nordisk A/S
$401.1k
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