New · posted Nov 1
Abbott · Medical Devices
Clinical Safety Program Lead
- Maple Grove, MN
- On-site
- Full-time
- Senior & Principal
The role
The Clinical Safety Program Lead combines clinical study leadership, project management, and medical safety oversight to drive the successful execution of global clinical investigations. Serving as both the operational portfolio lead and study-level safety expert, this role partners closely with Safety leadership and ensures studies are delivered efficiently while maintaining the highest standards of subject safety, scientific integrity, data quality, and regulatory compliance across the assigned portfolio. The individual is responsible for driving operational decisions, identifying gaps, developing solutions, and leading end-to-end data quality and safety processes. This individual anticipates and mitigates risks, proactively escalates and resolves issues, and drives execution against critical timelines in partnership with cross-functional stakeholders. A key focus of the role is supporting ongoing priority studies while leading execution of upcoming IDE clinical investigations, ensuring consistent, inspection-ready delivery and successful clinical development outcomes across the portfolio.
The ideal candidate brings a unique blend of clinical research operations experience, project management expertise, and clinical or medical knowledge, enabling them to lead complex studies, evaluate safety data, influence cross-functional decision-making, and provide strategic guidance throughout the clinical development lifecycle. They are recognized as a trusted team member who can balance operational execution with safety oversight while fostering accountability, collaboration, and continuous process improvement, in partnership with Safety leadership.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
What you need
Required Qualifications
- Bachelor's degree in nursing, Pharmacy, Life Sciences, Biomedical Engineering, Public Health, or related field.
- 5+ years of clinical research experience.
- Experience leading global clinical studies and cross-functional teams.
- Experience in clinical safety, pharmacovigilance, medical monitoring, or safety surveillance.
- Experience in project management role or equivalent
- Strong knowledge of GCP, ISO 14155, FDA regulations, MDR, and global clinical research requirements.
- Excellent communication, leadership, and problem-solving skills.
Preferred Qualificationsnice to have
- Advanced clinical degree (MD, PharmD, DNP, NP, PA-C, MSN, PhD, or equivalent).
- Medical device, structural heart, vascular, or cardiac rhythm therapeutic area experience.
- Experience serving as a Medical Monitor, Safety Lead, or Clinical Safety professional.
- PMP certification or advanced project management training.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
What you'll do
What You’ll Work On
- Lead the operational execution and safety oversight of global clinical studies from start-up through study closeout.
- Serve as the primary safety lead for assigned portfolio, providing expert assessment of safety data, emerging trends, and potential risks.
- Support operational decision-making by identifying gaps, developing solutions, and influencing cross-functional teams.
- Develop and implement study-specific safety management strategies and risk mitigation plans.
- Identify operational risks and implement mitigation strategies to maintain study timelines and quality standards and escalate risk to leadership.
- Lead end-to-end data review, data cleaning, and quality initiatives to ensure accurate, reliable, and inspection-ready study data.
- Partner with Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and Product Development to ensure successful study execution.
- Oversee external committees including Data Monitoring Committees and Clinical Events Committees.
- Drive protocol development, study design, endpoint definitions, and safety monitoring approaches across assigned portfolio.
- Ensure timely and compliant safety reporting to regulatory authorities, investigators, ethics committees, and internal stakeholders.
- Provide clinical interpretation of safety data and support regulatory submissions, clinical study reports, and health authority interactions.
- Drive inspection readiness, process improvements, and best practices across clinical operations and safety functions.
- Mentor team members and contribute to a culture of collaboration, accountability, continuous improvement, and patient focus.
- Anticipate study risks, proactively identify issues, and escalate critical concerns to ensure timely resolution.
- Maintain awareness of emerging clinical evidence, disease-state developments, and competitive technologies.
- Establish and drive study timelines, deliverables, and action plans while holding teams accountable for execution.
- Contribute to development and revision of SOPs, work instructions, and best practices.
Pay and benefits
$99,300 – $198,700 a year
Employer providedThe base pay for this position is
$99,300.00 – $198,700.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage through Health Investment Plan (HIP) PPO
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Maple Grove, MNOn-siteOpen in Maps (opens in a new tab)
More jobs in Maple Grove, MNWorking conditions
Standard
TRAVEL
Yes, 20 % of the Time
MEDICAL SURVEILLANCE
No
JOB FAMILY
Medical & Scientific Affairs
DIVISION
MD Medical Devices
LOCATION
United States > Maple Grove : 6820 Wedgwood Road N.
From the posting
About Abbott
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% below the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US12 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $99,300 | — | $198,700 |
| All US (middle half) | $148,000 | $172,000 | $195,125 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 162 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- Clinical trial conduct9
- GMP and compliance4
- Documentation and SOPs3
- Quality systems and risk3
- Investigations and CAPA2
- Regulatory submissions2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Abbott on Regulatory Jobs
- 108
- Open roles
- 98
- Distinct roles
- 32
- Locations
By discipline
- Quality61 56%
- Regulatory30 28%
- Clinical16 15%
By level
- Senior & Principal50 46%
- Associate & Specialist33 31%
- Manager21 19%
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Clinical Safety Program Lead at Abbott
Open until filled. $99K–$199K a year, employer provided.