Clinical Scientist

Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

The Clinical Scientist will play a critical role in the design, execution, and reporting of clinical studies, with a strong focus on regulatory submissions, including New Drug Applications (NDAs). This position requires expertise in clinical trial data analysis, protocol development, and regulatory documentation, ensuring alignment with global regulatory standards. The ideal candidate will work cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Medical Writing teams to drive the success of clinical programs.

Key Responsibilities:

• Provide scientific and strategic leadership in clinical study design, execution, and data interpretation.
• Author, review, and contribute to regulatory submissions, including NDAs, BLAs, MAAs, INDs, and briefing documents.
• Develop and review clinical study protocols, Investigator’s Brochures (IBs), and Clinical Study Reports (CSRs).
• Collaborate with Medical Writing to ensure high-quality clinical sections for regulatory filings.
• Analyze and interpret clinical trial data, ensuring alignment with regulatory expectations and company objectives.
• Work closely with Regulatory Affairs to support responses to regulatory agencies and advisory meetings.
• Partner with Biostatistics and Data Management teams to review statistical analysis plans and data outputs.
• Support clinical development planning, including target product profiles, clinical development plans, and risk assessments.
• Contribute to scientific publications and conference presentations.
• Provide clinical expertise in cross-functional meetings, including regulatory agency interactions.

Qualifications & Experience:

• Advanced degree (PhD, PharmD, or equivalent) in life sciences or a related field.
• Around 10 years of experience in clinical development, clinical research, or regulatory affairs within the pharmaceutical or biotechnology industry.
• Demonstrated experience in writing and reviewing NDAs, including Module 2 clinical summaries and Module 5 clinical study reports.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements for drug development.
• Experience working with FDA, EMA, and other global regulatory agencies.
• Expertise in data interpretation and analysis to support clinical and regulatory strategy.
• Excellent scientific writing and communication skills.
• Ability to work collaboratively in cross-functional teams.
• Experience with MAAs, BLAs, and other global regulatory submissions is a plus.

Preferred Qualifications:

• Prior experience in GI therapeutic areas.
• Familiarity with clinical trial databases, statistical software, and medical writing tools.
• Experience in post-marketing studies and lifecycle management of approved products.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts. 

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Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration. 

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com  or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number. 

Job Applicants should be aware of job offer scams perpetrated through the Internet and social media platforms. 
To learn more please read Bausch Health's Job Offer Fraud Statement.