Manager, Clinical Pharmacology

Company: Bausch Health
Location: South Bend
Posted on: January 23, 2023

Job Description:

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 peoples lives with our health care products.The Clinical Pharmacology Department is seeking an experienced and talented individual to lead a clinical pharmacology team that will enable and assist the early- and late-stage clinical development of internal pipelines. As a subject matter expert, this person will be responsible for the strategic planning and tactical execution of clinical pharmacology, pharmacometrics, and model-based approaches to support drug development. The ideal candidate will represent their function on study and project teams and will ensure the successful design and execution of development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics, and drug-drug interactions of the drug candidates in clinical settings. Prior experience with preparation and review of regulatory filing documents to support IND, IB, FIH, CTA and NDA/BLA filings is essential. Knowledge of ICH requirements for clinical pharmacology is essential. Experience in dealing with global development and small molecules, peptides proteins, recombinant molecules and biologic molecules is preferred.PRIMARY RESPONSIBILITIES:

• Providing scientific leadership on clinical pharmacology to support R&D and corporate strategy
• As Clin Pharm program lead, supports development project teams across diverse therapeutic areas that containing small molecule and protein therapeutics, contribute to the project strategies
• Supervising, developing, and mentoring junior level scientists.
• Developing and implementing new clinical pharmacology tools and technologies to drive smarter drug development for programs.
• Developing and maintaining collaborative working relationship with colleagues within and outside the department.
• Design, execute, analyze, and present related data to internal project teams and senior management.
• Developing clinical pharmacology plans, timelines, and priorities to meet regulatory requirements across Phase 1 3 studies, Phase 4, or post marketing studies as well as bioequivalence studies: ensuring proper design and flawless execution of dedicated clinical pharmacology studies where applicable
• Oversee and ensure the proper conduct of PK and PK/PD analyses, and guide PK/PD modeling and simulation work as needed to for various drug discovery and development programs
• Developing model-based justifications for optimal doses selected for clinical studies including pediatric dosing justification
• Providing effective communication with cross-functional groups, working closely with clinical study team and due diligence teams
• Authoring/reviewing/approving relevant sections of clinical protocols, analysis plans, study reports and regulatory submissions.
• Maintaining a high standard for good clinical practice, compliance, and ethics
• Maintaining and establishing relationships and agreements with contract vendorsQUALIFICATIONS:
  • 5+ years experience in clinical pharmacology required
  • Ph.D. or PharmD in Pharmaceuticals Sciences, Pharmacokinetics, Drug Metabolism, or a related field required
  • Experience in population modeling and simulations; manage analysis, including population PK modeling, PK-PD modeling, and simulation to support dose selection, exposure-response, and exposure-safety analyses
  • Has written and authored IND, NDA/BLA, global regulatory filing sections related to clinical pharmacology and pharmacology
  • Has experience with interaction with FDA and other regulatory agencies
  • Understanding and ability to apply appropriate regulatory and ICH guidelines in the design, analysis, and interpretation of clinical pharmacology studies
  • Strong written, verbal, and interpersonal communications skills including ability to communicate scientific information clearly and effectively
  • Demonstrated ability to work effectively with cross-functional groups in a matrix team environment.
  • Has experience evaluating and selecting vendors for clinical pharmacology studies
  • Has expertise in using modelling and simulation software (GastroPlus. WinNonlin etc)
  • Has experience in managing a group of scientistsAs required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is 170k 180K.Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), Employee Stock Purchase Plan, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating 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.This position may be available in the following location(s): [[location_obj]]All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.To learn more please readBausch Health's Job Offer Fraud Statement (https://valeant.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=224770&hashed=-1624416981) .Bausch Health is an EEO/AA employer M/F/D/V.

Keywords: Bausch Health, South Bend , Manager, Clinical Pharmacology, Executive , South Bend, Indiana