Director, Clinical Pharmacology

Bausch & Lomb GmbH; Bridgewater (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director of Clinical Pharmacology to join their innovative team. This role involves providing expertise in pharmacokinetics and pharmacodynamics, leading strategic drug development initiatives, and collaborating with cross-functional teams to ensure compliance with regulatory standards. The ideal candidate will have a Ph.D. or Pharm.D. with significant experience in the pharmaceutical industry, particularly in clinical pharmacology. This position offers an exciting opportunity to shape the future of healthcare and make a meaningful impact on patient outcomes while working in a supportive and dynamic environment.

Benefits

Comprehensive Medical Insurance

Dental Insurance

Vision Insurance

401(k) Matching

Tuition Reimbursement

Paid Sick Time

Flexible Spending Accounts

Employee Discounts

Paid Holidays

Employee Referral Bonuses

Qualifications

• 10+ years of experience in clinical pharmacology and drug development.
• Strong background in pharmacokinetics and pharmacodynamics.

Responsibilities

• Lead clinical pharmacology strategy for drug development programs.
• Oversee Phase I-III studies and manage staff scientists.

Skills

Pharmacokinetics

Pharmacodynamics

Drug Development

Leadership Skills

Excellent Communication

Education

Ph.D. in Pharmaceutical Sciences

Pharm.D. with Clinical Pharmacology Training

M.S. with Significant Experience

Tools

Phoenix WinNonlin

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, and medical aesthetic devices. 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.

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 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 be 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 guidance, 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: 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, NJ

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 [e-mail] 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.