Director - Safety Surveillance

15+ years

Not Disclosed

Plainsboro

10 Jan. 8, 2025

Job Description

Job Type: Full Time Education: MD/PhD 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: Director, Safety Surveillance (Leadership Role)

Location: U.S. East Coast Development Hub, Novo Nordisk
Facilities: Lexington, Watertown, Cambridge, Seattle

About the Department

Novo Nordisk's Research & Development organization brings together some of the brightest minds in life science innovation. With facilities across Lexington, Watertown, Cambridge, and Seattle, we cover the full R&D continuum, from early research through late-stage clinical development. We are committed to building a future-focused R&D community grounded in collaboration, partnerships, and cutting-edge research in multiple therapeutic areas. We blend the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company to create new medicines that make a difference in patients’ lives.

The Position

This leadership role will oversee the safety surveillance sub-function within the U.S. East Coast Development Hub. The team consists of Senior Global Safety Leads, Global Safety Leads, Senior Global Safety Scientists, and Safety Scientists. The role is responsible for contributing to the development of safety strategies and delivering high-quality safety profiles for assigned programs, collaborating closely with internal stakeholders across multiple functional areas.

In this position, you will play a key role in managing organizational design, training, and planning while ensuring the safety of Novo Nordisk products from pre-approval to post-approval stages.

Key Responsibilities

Leadership and Strategy

Lead a team in the safety surveillance sub-function, including mentoring and developing staff.
Oversee the creation of safety strategies and deliverables for assigned programs, collaborating with Global Safety Surveillance and other cross-functional teams.
Manage operational functions, aligning them with company-wide policies, procedures, and goals.
Provide oversight and innovation to improve methods, techniques, and strategies within the safety surveillance area.
Ensure global scalability of safety solutions and consider cross-functional impacts of decisions.

Safety Surveillance & Communication

Develop and update safety-related materials, such as the minimum mandatory safety text (MMST) for Informed Consent and the Company Core Data Sheet (CCDS) for product labeling.
Maintain product labeling and participate in the Product Labelling Committee (PLC) Review Group.
Ensure continuous safety surveillance across pre-approval and post-approval phases for all allocated product areas.
Conduct periodic literature surveillance for marketed and development products, preparing necessary Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and other safety documents.
Participate in cross-functional safety committees and establish safety input for the entire lifecycle of a product.
Serve as the safety representative in trial squads, Global Project Teams (GPTs), and other cross-functional groups, ensuring safety integration into all project activities.

Collaboration with Internal and External Stakeholders

Provide safety input to clinical trial protocols, investigator brochures, and clinical trial reports.
Lead communication with Healthcare Authorities (HAs) and Ethics Committees (ECs) regarding safety aspects of protocols and patient information.
Review and approve safety surveillance deliverables from the team and maintain collaboration with Data Monitoring Committees (DMCs).

Development of People

Oversee staff development, ensuring that all team members have Individual Development Plans (IDPs) aligned with business goals and priorities.
Ensure that learning and aspiration plans are in place for team members to support their professional growth and increase their responsibilities.

Physical Requirements

Approximately 10% overnight travel required.
Ability to lift 0-10 lbs.

Qualifications

Education

MD, PhD, or equivalent in a relevant field, or a life sciences/pharmacy/nursing degree with at least 15 years of experience in global safety surveillance or clinical/drug development.

Experience

10+ years of relevant experience in global safety surveillance or clinical/drug development.
Strong knowledge of clinical trial design, safety reporting, and regulatory requirements.
Proven track record of leading cross-functional teams and managing complex safety issues.
Experience in handling safety surveillance during both pre-approval and post-approval phases.
Experience working with Healthcare Authorities (HA) and Ethics Committees (ECs).

Skills

Excellent verbal and written communication skills.
Strong organizational and problem-solving capabilities.
Ability to thrive in a fast-paced environment while maintaining a positive attitude under pressure.

Equal Opportunity Employer

Novo Nordisk is committed to creating an inclusive culture that celebrates diversity, bringing together employees, patients, and communities to foster meaningful change. We are an equal opportunity employer, offering consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status.

For special assistance or accommodations during the application process, please contact 1-855-411-5290.

Apply Now: Novo Nordisk Careers

Together, we’re life-changing.

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