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    Cdo Senior Portfolio Director - Cardiovascular Therapy Area (Plainsboro Nj Or Remote)

    Novo Nordisk
    12+ years
    Not Disclosed
    Plainsboro
    10 Jan. 8, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Clinical Trial Manager

    Location: Plainsboro, NJ (or Remote in the U.S.)
    Company: Novo Nordisk

    About the Department

    The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups in the organization. From healthcare provider interactions and regulatory strategy development to medical education and data collection, CMR’s work supports the development of innovative treatments that improve patients' lives.

    At Novo Nordisk, we embrace a patient-centered focus. Our team is driven by a mission to meet the evolving needs of patients, discovering better ways to enhance their quality of life. We’re changing lives for a living—are you ready to make a difference?

    The Position

    The Senior Clinical Trial Manager will oversee portfolio strategy, cross-functional study management, and trial deliverables, ensuring compliance with timelines, budgets, and quality standards. This role includes building strong relationships with internal teams, clinical sites, and external service providers while driving operational excellence.

    Key Responsibilities

    Planning & Strategy:

    • Develop and implement operational plans for the assigned Therapy Area in collaboration with the Operations Director and Therapy Area Heads.
    • Set goals, establish priorities, and align strategies with business needs and resource availability.

    Study Management:

    • Lead cross-functional study teams and manage external partners (e.g., CROs, vendors, clinical sites) to achieve trial objectives.
    • Monitor trial risks, timelines, budgets, and performance metrics, ensuring timely reporting to relevant stakeholders.
    • Collaborate on site selection, patient recruitment strategies, and performance optimization.

    People Management:

    • Provide supervision and performance management for direct and indirect reports.
    • Foster team collaboration, employee engagement, and professional development.

    Change & Innovation:

    • Identify operational inefficiencies and implement process improvements.
    • Champion a culture of continuous improvement, leveraging new tools and technologies.

    Resource & Financial Management:

    • Collaborate with internal teams to optimize resource allocation and manage budgets.
    • Track expenditures and implement cost-saving measures without compromising quality.

    Risk Management:

    • Ensure compliance with ICH-GCP guidelines, internal SOPs, and regulatory requirements.
    • Train staff and stakeholders on industry best practices to mitigate risks.

    Cross-Functional Collaboration:

    • Partner with internal and external stakeholders to align trial activities and share best practices.
    • Maintain strong relationships with investigators, site staff, and regulatory authorities.

    Qualifications

    Education:

    • Required: Bachelor’s degree in a scientific or health-related field.
    • Preferred: Advanced degree (Master’s, Ph.D., or equivalent).

    Experience:

    • 12+ years of clinical trial experience in the pharmaceutical/biotechnology industry, with 10+ years in clinical, medical, or regulatory roles.
    • 7+ years of supervisory experience.
    • Proven experience leading cardiovascular clinical trial portfolios or programs (e.g., heart failure).
    • Direct experience with regulatory authorities, such as the FDA, in clinical trial design and execution.

    Skills:

    • Expertise in ICH-GCP principles and clinical trial processes.
    • Exceptional communication skills (written, verbal, presentation) in English.
    • Strong leadership, organizational, and change management skills.
    • Experience designing and implementing operational improvements or innovations.

    Compensation and Benefits

    • Base Salary Range: $250,000–$275,000 (commensurate with experience).
    • Additional Compensation: Annual performance-based bonuses, long-term incentive plans, and/or company vehicle (if applicable).
    • Benefits: Comprehensive medical, dental, vision, life insurance, disability coverage, 401(k) savings plan, tuition reimbursement, flexible spending accounts, and employee assistance programs.
    • Time Off: Sick leave, flexible vacation policy, and parental leave.

    Equal Opportunity Employer

    Novo Nordisk is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, ethnicity, gender, religion, sexual orientation, disability, veteran status, or other protected characteristics.

    If you require special assistance or accommodations to apply, contact us at 1-855-411-5290 (for accommodation requests only).

    Application Deadline

    This position is open until January 8, 2025, with the possibility of extension.

    Apply Now: Novo Nordisk Careers

    Together, we’re life-changing.

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