Sr. Global Program Safety Team Lead - Oncology
Novartis
June 29, 2026
Remote friendly (East Hanover, NJ)
United States
Clinical Research and Development
Responsibilities:
- Manage an efficient and successful disease area within the TA/DU Medical Safety organization; contribute to Benefit-Risk evaluation across the product lifecycle.
- Enhance scientific/clinical experience through training and coaching; prepare safety objectives; evaluate/manages performance of Medical Safety associates; identify talent and high potential associates.
- Provide expert safety input to clinical development for assigned projects/products; serve as a member of GPT/GCT/CTT; manage safety issues from GPT formation through life cycle management.
- Lead overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information (including post-marketing data and other sources).
- Document/track/maintain medical safety activities for assigned compounds; respond to inquiries from regulatory authorities and/or healthcare professionals on safety issues.
- Lead preparation of health authority safety strategy responses in collaboration with project teams.
- Contribute to and often lead development of departmental/functional/business unit goals and objectives.
Qualifications (Essential):
- Medical Degree or equivalent (preferred); PhD/PharmD/equivalent required; Specialty Board certification desirable.
- Minimum 5 years clinical experience postdoctoral.
- At least 7 years progressive pharma drug development experience (5 years in global position), including 5 years in safety in a medical position.
- Expertise preparing clinical safety assessments and regulatory safety reports/submissions (including NDA documents).
- Substantial experience leading cross-functional, multicultural teams.
- Strong experience with safety/other issue management.
- Extensive experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and publication writing.
- Strong leadership skills (coaching, motivating/directing, teamwork) and ability to maintain effective working relationships.
Languages:
- Fluent English (spoken & written) required; additional languages an advantage.
Beneficial/Preferred:
- Postgraduate degree in Pharmaceutical Medicine or Master of Public Health in Epidemiology (or equivalent).
- Strong negotiation and conflict management skills.
- Strong medical writing experience; deliver high-quality documents such as RMPs and PSURs.
Application instruction:
- Closing date for applications: 06 July 2026
- Manage an efficient and successful disease area within the TA/DU Medical Safety organization; contribute to Benefit-Risk evaluation across the product lifecycle.
- Enhance scientific/clinical experience through training and coaching; prepare safety objectives; evaluate/manages performance of Medical Safety associates; identify talent and high potential associates.
- Provide expert safety input to clinical development for assigned projects/products; serve as a member of GPT/GCT/CTT; manage safety issues from GPT formation through life cycle management.
- Lead overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information (including post-marketing data and other sources).
- Document/track/maintain medical safety activities for assigned compounds; respond to inquiries from regulatory authorities and/or healthcare professionals on safety issues.
- Lead preparation of health authority safety strategy responses in collaboration with project teams.
- Contribute to and often lead development of departmental/functional/business unit goals and objectives.
Qualifications (Essential):
- Medical Degree or equivalent (preferred); PhD/PharmD/equivalent required; Specialty Board certification desirable.
- Minimum 5 years clinical experience postdoctoral.
- At least 7 years progressive pharma drug development experience (5 years in global position), including 5 years in safety in a medical position.
- Expertise preparing clinical safety assessments and regulatory safety reports/submissions (including NDA documents).
- Substantial experience leading cross-functional, multicultural teams.
- Strong experience with safety/other issue management.
- Extensive experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and publication writing.
- Strong leadership skills (coaching, motivating/directing, teamwork) and ability to maintain effective working relationships.
Languages:
- Fluent English (spoken & written) required; additional languages an advantage.
Beneficial/Preferred:
- Postgraduate degree in Pharmaceutical Medicine or Master of Public Health in Epidemiology (or equivalent).
- Strong negotiation and conflict management skills.
- Strong medical writing experience; deliver high-quality documents such as RMPs and PSURs.
Application instruction:
- Closing date for applications: 06 July 2026