Johnson & Johnson
Global healthcare company offering pharma, devices.
Manager Clinical Research
Hybrid work arrangement; up to 20% domestic and international travel may be required.
About the job
- 6–8 years of progressive clinical research or clinical operations experience, including substantive hands-on experience conducting or overseeing industry-sponsored clinical research, preferably for medical devices.
- Demonstrated experience managing medical device clinical studies across multiple phases of execution, such as feasibility, study start-up, site management, monitoring oversight, vendor/CRO management, close-out, or post-market evidence generation.
- Knowledge of medical device clinical research standards and regulations, including ISO 14155, applicable Good Clinical Practice principles, ethics requirements, safety reporting, and quality-system expectations.
- Experience working with global and local cross-functional teams and communicating regional evidence needs, risks, and recommendations to global stakeholders.
- Proven ability to manage CROs, vendors, clinical sites, multiple priorities, timelines, and stakeholders in a matrix environment.
- Excellent written and verbal communication skills, including preparation and review of clinical, scientific, operational, and regulatory documentation.
- English proficiency is required.
- Serve as the Australia-based clinical research lead and primary interface with the global clinical team, bringing forward regional clinical practice, customer, regulatory, reimbursement, and evidence needs to inform global evidence-generation plans.
- Partner with Medical Affairs, Regulatory, Market Access, Research and Development, Marketing, and other local stakeholders to identify evidence gaps and priorities for Australia and the broader region, and translate them into clear recommendations for the global clinical strategy.
- Lead or support local execution of medical device clinical studies, including feasibility, site identification and selection, start-up, enrollment, monitoring oversight, issue resolution, close-out, and study documentation.
- Manage local contract research organization and vendor activities, including scope alignment, performance oversight, timeline and budget tracking, risk escalation, and quality of deliverables.
- Build and maintain effective relationships with orthopedic investigators, clinical sites, research networks, and relevant national or regional clinical quality registries.
- Support interactions and evidence activities involving the Australian Orthopaedic Association National Joint Replacement Registry and other national joint or medical device registries, including data requests, analyses, research collaborations, and interpretation of registry evidence.
- Ensure studies are conducted in compliance with ISO 14155, International Council for Harmonisation Good Clinical Practice as applicable, Australian regulatory and ethics requirements, other relevant country regulations, and internal quality procedures, with strong oversight of informed consent, safety reporting, essential documents, and data integrity.
- Develop and maintain operational study plans, enrollment projections, milestones, monitoring approaches, and escalation pathways; proactively identify and mitigate risks to timelines, budget, quality, and evidence deliverables.
- Support audit and inspection readiness by maintaining complete study documentation, coordinating responses, facilitating interviews, and driving timely completion of corrective and preventive actions for study-related findings.
- Provide clear status reporting, decision support, and timely handoffs across time zones to maintain alignment between local stakeholders and the United States-based global clinical team.
- Clinical research experience in orthopedics, joint replacement, trauma, spine, sports medicine, or other implantable or surgical medical devices.
- Experience interacting or collaborating with the Australian Orthopaedic Association National Joint Replacement Registry, another national joint replacement registry, or a comparable medical device or clinical quality registry.
- Experience using registry or real-world data to identify evidence gaps, support post-market surveillance, evaluate device performance, or inform clinical, regulatory, reimbursement, or market access strategies.
- Knowledge of the Australian medical device research environment, including local ethics, governance, regulatory, site, and investigator requirements.
- Experience supporting regulatory submissions, post-market clinical follow-up, investigator-initiated research, or externally sponsored research for medical devices.
- Prior matrix leadership or people-management experience.
- Clinical research or project management certifications, such as Association of Clinical Research Professionals, Society of Clinical Research Associates, or Project Management Professional.
About the company
Johnson & Johnson operates in three main areas—pharmaceuticals, medical devices, and consumer health products—serving consumers, healthcare professionals, and institutions worldwide. It develops prescription medicines, sells surgical and vision care devices, and offers over-the-counter and personal care products, funded by direct sales, partnerships, and distribution agreements, with heavy investment in research and development. The company differentiates itself by combining three complementary businesses under one umbrella and maintaining a global footprint with an emphasis on science, innovation, and inclusive culture. Its goal is to help people live healthier lives by delivering reliable, high-quality healthcare products and solutions that improve patient outcomes.
Company Size
10,001+
Company Stage
IPO
Headquarters
New Brunswick, New Jersey
Founded
1886
Get referred to Johnson & Johnson
See people who can refer or advise you
Simplify's Take
What believers are saying
- Carvykti topped $1 billion annual sales in January 2026, strengthening oncology.
- IMAAVY won FDA approval on August 24, 2026, expanding a second launch.
- Q2 2026 sales rose 6.6% to $25.31 billion, and guidance increased.
What critics are saying
- The July 2026 talc settlement covers only existing claims, leaving future lawsuits open.
- CVS dropped Stelara from main formularies in May 2026, accelerating biosimilar pressure.
- Carvykti’s FDA boxed warning and Legend partnership constrain multiple myeloma expansion.
What makes Johnson & Johnson unique
- J&J spans Innovative Medicine and MedTech, reducing dependence on any single franchise.
- Carvykti and IMAAVY show J&J still converts R&D into first-in-class approvals.
- Its oncology and immunology franchises offset Stelara’s erosion.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
401(k) Company Match
Paid Vacation
Paid Sick Leave
Paid Holidays
Remote Work Options
Performance Bonus
Growth & Insights and Company News
6 month growth
↓ -4%1 year growth
↓ -4%2 year growth
↓ -3%Johnson & Johnson shares rose roughly 1% to $277.96 Thursday after AbbVie announced its experimental multiple-myeloma drug, etentamig, achieved a 74% response rate and reduced the risk of disease progression or death by 60% compared to standard therapies. AbbVie's trial positions a convenient monthly treatment in the myeloma market for potential outpatient use. However, J&J is defending its growing franchise, with Carvykti driving 6.8% operational growth in Innovative Medicine during the second quarter. According to Reuters, etentamig appears most differentiated after CAR-T therapy rather than as a direct Carvykti substitute. The market is treating AbbVie's advancement as category expansion rather than a direct threat to J&J. J&J's current share price stands 44.08% above its $192.92 valuation estimate, making future safety and durability data critical for investors.
Procter & Gamble's dividend strategy is outpacing Johnson & Johnson's despite J&J's stronger stock performance this year. J&J's forward annualised dividend of $5.36 exceeds P&G's $4.354, but its planned mid-2027 DePuy Synthes spinoff threatens its dividend streak. P&G CEO Shailesh Jejurikar committed $10 billion in dividends and $5 billion in buybacks for fiscal 2027, supported by $2.8 billion in productivity savings. The company returned over $15 billion to shareholders in fiscal 2026, including more than $10 billion in dividends. J&J's stock surged 28.5% year-to-date versus P&G's 1.3% gain, driven by strong product performance. However, the upcoming spinoff poses uncertainty, as similar corporate events have disrupted other companies' dividend streaks. P&G faces no such structural risk.
Johnson & Johnson has significantly outperformed the consumer staples sector, with shares rising 52.8% over the past 52 weeks compared to the State Street Consumer Staples Select Sector SPDR Fund's 6.5% gain. The New Brunswick-based healthcare giant, valued at $640.5 billion, has seen particularly strong momentum recently, climbing 16.1% over three months. The company's strong performance follows solid second-quarter results released on 15 July, where sales increased 6.6% year-over-year to $25.31 billion. Adjusted earnings per share of $2.90 exceeded market expectations. Johnson & Johnson raised its full-year guidance, projecting adjusted EPS of $11.58 and sales of $101.1 billion. The stock currently trades just 3.1% below its 52-week high of $276.47, reached on 19 August.
AbbVie and Johnson & Johnson present distinct investment profiles in the healthcare sector. AbbVie focuses on biopharmaceuticals in immunology, oncology, and aesthetics, reporting fiscal 2025 revenue of $61.2 billion, up 8.7% year-over-year. Net income reached $4.3 billion with a 7% margin. The company generated $17.8 billion in free cash flow despite a negative debt-to-equity ratio of -21x. Johnson & Johnson operates through Innovative Medicine and MedTech segments. Revenue hit $94.2 billion in fiscal 2025, rising 6%. Net income nearly doubled to $26.8 billion from $14.1 billion the previous year, yielding a 29% margin. Its Darzalex portfolio accounted for 15% of total revenue. AbbVie relies heavily on three wholesale distributors for US sales, creating concentration risk. Johnson & Johnson maintains broader distribution globally.
Johnson & Johnson's stock surged 54% between late August 2025 and late August 2026, outpacing the S&P 500's 20.5% return. The driver was a product transition that management flagged seven months before the rally began. STELARA faced biosimilar competition and declined 43.2% by mid-2025. Management named TREMFYA as its replacement, targeting the same inflammatory bowel disease patients who comprised 70% of STELARA's prescriptions. TREMFYA grew 30.1% during the same period. By July 2026, TREMFYA posted its first $2 billion quarter with 71% growth, offsetting STELARA's 55.7% decline. This product swap lifted the company's operational sales outlook to a $100.6 billion midpoint, demonstrating revenue durability despite losing a major franchise.