Director, Clinical Pharmacology

Company: Bausch Health
Location: Bridgewater
Posted on: February 13, 2025

Job Description:

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 Director of Clinical Pharmacology will provide expertise and support to internal and external stakeholders in areas including, but not limited to, pharmacokinetics, pharmacometrics, drug metabolism, bioanalysis, and nonclinical pharmacology. -The incumbent will serve as the clinical pharmacology subject matter expert in cross-functional project teams and sub-teams, and lead the strategy, design, interpretation and reporting of clinical pharmacokinetics, pharmacodynamics, and drug-drug interaction studies. -The individual will discuss clinical pharmacology, formulation, and pharmacokinetic issues with R&D staff, senior management, consultants and regulatory authorities in order to convey key concepts and facilitate understanding of results and risks. -Daily interactions are expected with senior management and/or their direct reports. -This position will manage staff scientists and provide project support as an individual contributor.Responsibilities:Represent the clinical pharmacology function in cross-functional project teams including Project Management, CMC, Analytical Sciences, Nonclinical, Clinical Operations, Clinical/Medical Affairs, Biostatistics, and Regulatory Affairs.Lead the clinical pharmacology strategy of early and late-stage drug development programs and responsible for the design, technical oversight, data analyses and interpretation of clinical pharmacology studies. Critically review study reports and literature and summarize key information for presentation to internal and external audiences as needed.Work with internal stakeholders and external consultants to address specific scientific issues.Collaborate closely with the clinical project team to oversee and manage Phase I-III studies and post-marketing studies.Oversee bioanalytical activities in support of clinical and nonclinical studies at contract research organizations.Plan and assist in the execution of proof-of-concept studies to evaluate novel drug product formulations.Responsible for the technical content and timely completion of clinical pharmacology deliverables as well as regulatory submissions including relevant sections in clinical study protocols and reports, PK analysis plans, IBs, INDs, NDAs, etc. Ensure compliance with current regulatory guidances, as appropriate.Manage and mentor clinical pharmacology staff.Education:Ph.D. in pharmaceutical sciences, pharmacology, or related field, or Pharm.D. with clinical pharmacology and pharmacokinetic training and experience. M.S. degrees with significant applicable experience will also be considered.Minimum of 10 years of experience in clinical pharmacology, pharmacokinetics and/or drug development in the pharmaceutical industry. Experiences and Skills:Pharmaceutical industry experience with a strong background in pharmacokinetics, pharmacodynamics, and PK/PD analyses.Hands-on experience with non-compartmental PK/PD analysis using Phoenix WinNonlin, and familiarity with population modeling is strongly preferred. Previous experience with gastroenterology and dermatology drugs is preferred.Track record of successful regulatory agency (U.S. FDA) submissions and interactions preferred.Strong interpersonal, teamwork, organizational and workload planning skills, as well as excellent written and verbal communication skills are required. Leadership skills, initiative, attention to detail and accuracy, and an overall commitment to excellence are required. Ability to work in a matrix environment and to act independently and take initiative with minimal supervision.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.#LI-hybrid This position may be available in the following location(s): -United States - Bridgewater, NJBausch 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.

Keywords: Bausch Health, New Brunswick , Director, Clinical Pharmacology, Executive , Bridgewater, New Jersey