Senior Director, Clinical Pharmacology

Date: Sep 23, 2022

Location: US-CA-Petaluma, California, US

Company: Bausch Health

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 is preferred. Broad experiences with small molecules, peptides proteins, recombinant molecules and biologic molecules is preferred.  Will report to Vice President of R&D.

 

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 postmarketing 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 vendors

 

QUALIFICATIONS

  • Ph.D or PharmD in Pharmaceuticals Sciences, Pharmacokinetics, Drug Metabolism or a related field with minimally 8-10 years of industry experience in clinical pharmacology
  • Has 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
  • Has experience working with small molecules and large molecules such as peptides, proteins, recombinant proteins, biologic molecules
  • 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 scientists