Sr. Clinical Operations Portfolio Director- Cardiovascular(Plainsboro Nj Or Remote)

Novo Nordisk

7-10 years

250k -275k $

Plainsboro United States

10 Feb. 13, 2025

Job Description

Job Type: Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Description

Position: Clinical Development Lead

Location: Plainsboro, United States
Job Category: Clinical Development
Application Deadline: January 8, 2025 (Subject to extension)

About the Department

The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is a dynamic and collaborative team that focuses on patient-centered innovation. From healthcare provider interactions to regulatory strategies with the FDA, CMR is integral to new product development and efficacy data collection. At Novo Nordisk, your work contributes to changing lives globally.

The Position

The Clinical Development Lead will drive portfolio strategy, study management activities, and manage cross-functional teams, CROs, and clinical trial sites to ensure trial deliverables are met within timelines, budgets, and quality standards.

Key Responsibilities:

✔ Trial Oversight & Management:

Proactively track, monitor, and report trial risks, progress, and financial metrics.
Identify, qualify, and manage relationships with clinical trial sites, PIs, and patient recruitment teams.

✔ Leadership & Team Development:

Manage Trial Managers & Clinical Study Leads (CSLs) to ensure successful execution of clinical trials.
Ensure the alignment of business plans with operational needs.
Provide leadership in a changing global environment by leveraging technology and change management skills.

✔ Strategic Planning & Execution:

Develop and implement goal setting, prioritization, and operational plans for the Therapy Area.
Analyze business needs and proactively identify opportunities and risks.

✔ Operational & Resource Management:

Track and forecast resource capacity in collaboration with OED.
Monitor expenses and implement cost-saving measures.
Ensure optimal resource utilization and allocation.

✔ Performance & Risk Management:

Track key performance indicators (KPIs) and ensure compliance with ICH, GCP, and regulatory guidelines.
Ensure trial conduct meets Novo Nordisk’s business and compliance standards.

✔ Cross-Functional Collaboration & Stakeholder Management:

Partner with internal departments including Operations, Finance, CMR, and International Operations.
Foster strong external relationships with contract research organizations (CROs), health systems, and investigators.

Qualifications:

✅ Education:

Bachelor's degree (required); Advanced degree (preferred).

✅ Experience:

12+ years of progressively responsible clinical trial experience in Pharma/Biotech/CRO.
7+ years of supervisory experience leading cross-functional teams.
Experience in cardiovascular clinical trials (heart failure preferred).

✅ Technical Expertise:

ICH-GCP principles and their application in clinical trials.
Direct experience with FDA regulatory interactions.
Expertise in innovation and change management.
Strong communication, leadership, and problem-solving skills.

Compensation & Benefits

💰 Base Salary: $250K – $275K (Based on experience & qualifications)
📈 Bonus: Eligible for company performance-based bonus
📊 Long-Term Incentives: Stock options & company vehicle (dependent on level and company factors)

Comprehensive Benefits Package Includes:
✔ Medical, dental, and vision coverage
✔ Life & disability insurance
✔ 401(k) savings plan
✔ Flexible spending accounts
✔ Tuition reimbursement
✔ Employee assistance programs
✔ Parental leave & flexible vacation policy

Additional Information:

📍 Work Environment:

10-20% overnight travel required.
Can work onsite in Plainsboro, NJ, or remotely anywhere in the U.S.
May be required to work company holidays and weekends.

📌 Equal Opportunity Employer:
Novo Nordisk is committed to diversity, equity, and inclusion. We welcome applicants from all backgrounds and provide reasonable accommodations for applicants with disabilities.

📞 Need Assistance?
For special accommodations during the application process, call 1-855-411-5290 (requests only—no application status inquiries).

👉 Apply Now: Novo Nordisk Careers

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Sr. Clinical Operations Portfolio Director- Cardiovascular(Plainsboro Nj Or Remote)

Job Description

Job Description

Position: Clinical Development Lead

About the Department

The Position

Key Responsibilities:

Qualifications:

Compensation & Benefits

Additional Information:

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