Assist in designing and interpreting data from PK/ PD studies in support of clinical and nonclinical development. - Interact with cross functional teams including Project Management, Clinical Operations, Clinical/ Medical Affairs, Biostatistics and Regulatory Affairs for the timely completion of deliverables related to clinical studies and regulatory submissions. - Represent the clinical pharmacology function in multi-disciplinary study teams including CROs. - Draft and review relevant clinical ... more details
Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 7,000 employees are united around our mission of improving people’s lives with our health care products.
JOB DESCRIPTION
- The clinical pharmacology manager will support the design, execution, interpretation and reporting of clinical pharmacokinetic/pharmacodynamic (PK/PD) studies.
- The individual will work with clinical pharmacology and R&D senior staff on early and late-stage development projects and provide support in characterizing the clinical pharmacology profile of drugs with an emphasis on dose and regimen selection.
- The individual will serve as the clinical pharmacology subject matter expert in cross-functional project teams and sub-teams, and will contribute to the planning, implementation, and organization of deliverables for regulatory filings along with analysis and presentation of PK/PD data to internal teams.
- Experience in translating preclinical data into clinical dosing schemes, including projection of PK in humans.
- Critically review internal reports and external literature and summarize key information.
- Collaborate closely with the clinical project team to oversee and manage Phase I-III studies and post-marketing studies.
RESPONSIBILITIES
• Assist in designing and interpreting data from PK/PD studies in support of clinical and nonclinical development.
• Interact with cross functional teams including Project Management, Clinical Operations, Clinical/Medical Affairs, Biostatistics and Regulatory Affairs for the timely completion of deliverables related to clinical studies and regulatory submissions.
• Represent the clinical pharmacology function in multi-disciplinary study teams including CROs.
• Draft and review relevant clinical pharmacology sections in clinical study protocols, PK analysis plans, study reports, IBs, INDs, NDAs, etc.
• Assist in the design and authoring of clinical pharmacology study protocols (e.g., food effect, PK, human ADME, drug-drug interactions, TQT, and hepatic/renal impairment).
• Attend meetings and communicate with CROs/vendors to ensure clinical pharmacology-related deliverables are completed on a timely manner with emphasis on strong technical conduct and in accordance with current regulatory guidances, when applicable.
EXPERIENCE / REQUIREMENT
• Pharmaceutical industry experience with a strong background in Pharmacokinetics and Pharmacodynamics, and PK/PD analyses
• Hands-on experience with non-compartmental and compartmental PK/PD analysis using Phoenix Win Nonlin software
• Excellent writing and verbal communication skills
• Ability to work in a matrix environment with different leadership styles
EDUCATION
• Pharm. D or Ph.D with 1+ years, MS with 3+ years, BS with 5+ years of experience in Pharmacokinetic/ Pharmacodynamic/ Clinical Pharmacology
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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This position may be available in the following location(s): US - Bridgewater, NJ
We thank you in advance for your interest in growing and developing with our company. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.
Any exception will have to be authorized by your HR Business Partner.
We are 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.
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