Associate Director, Clinical Pharmacology

Bausch+Lomb Companies Inc.•USA - Remote, OR

9d•$130,000 - $200,000•Remote

About The Position

This role will enable our aspiration of the Bausch + Lomb mission of helping people see better to live better. This is an opportunity for a highly motivated translational scientist to be a key scientific contributor to building a best-in-class pharmaceutical and consumer pipeline. Responsibilities: Scientific role that contributes through translational nonclinical PK, PK/PD, ADME, clinical pharmacology and pharmacometrics in establishing Bausch + Lomb as the leader in eye health scientific innovation. Technical Excellence Leads clinical pharmacology, PK, PD, and pharmacometrics activities across multiple programs spanning the Rx ophthalmic pipeline (e.g., dry eye, glaucoma, retinal disease, ocular surface disease) and consumer eye health pipeline. Contributes to action plans that best meet drug development business objectives, including candidate selection, first-in-human strategy, dose selection and justification, special population strategy, and life-cycle management. Provides overall clinical pharmacology timelines and deliverables to inform portfolio prioritization and resourcing decisions. Negotiates with other functional areas on project outcomes and deliverables to balance conflicting demands of time, cost, and quality/performance. Contributes to development of departmental goals and influences strategic PK/PD decisions for the department. Scientific and Technical Accountability Evaluates technical and scientific aspects of projects, including ocular and systemic PK, ocular bioavailability and distribution, PK/PD modeling, exposure–response analysis, population PK, PBPK, and quantitative systems pharmacology where applicable. Designs and oversees nonclinical PK, TK and clinical pharmacology studies, including first-in-human, ocular PK, drug–drug interaction, QT/QTc, hepatic/renal impairment, pediatric, and bioequivalence/bridging studies relevant to ophthalmic products. Applies scientific expertise to interpret clinical and nonclinical data and clearly communicates implications to management, including go/no-go recommendations. Mains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software (e.g., NONMEM, Monolix, Phoenix WinNonlin/NLME, R, Simcyp, GastroPlus, MATLAB). Regulatory Strategy and Submissions Reviews study protocols and reports including for regulatory filings and anticipates regulatory questions. Leads authoring of pharmacokinetics and clinical pharmacology sections of regulatory documents including IND/CTA, IB, briefing packages, pre-IND/EOP2/pre-NDA meeting materials, NDA/BLA/MAA/505(b)(2), DMFs, and periodic safety updates. Leads responses to health authority questions and represents Pharmacokinetics and Clinical Pharmacology in agency interactions. Ensures alignment with ICH, FDA, EMA, and other applicable guidance for ophthalmic and systemic products. Team Member Activities Identifies issues and supports issue resolution; conducts risk assessments and helps develop contingency plans; assures projects remain aligned with strategic objectives. Provides scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical development decisions. Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship. May conduct due diligence assessments for in-licensing, acquisition, and partnership opportunities; summarizes pharmacokinetic and clinical pharmacology findings and represents the function on due diligence teams. Communicates and presents key pharmacokinetics and clinical pharmacology information and strategy to management, regulatory agencies, external peers, scientific advisory boards, and KOLs.

Requirements

PhD in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmacology, Biomedical Engineering, or related discipline with typically 6+ years of relevant experience.
Experience with PK, PBPK, PK/PD, pharmacometrics or systems pharmacology, and/or drug metabolism and transporters.
Demonstrated leadership in PK/PD, biopharmaceutics, and pharmacometric activities from planning through implementation and completion across multiple projects.
Experience across a range of development phases (discovery support through Phase 3 and life-cycle management); experience with 505(b)(2), ANDA bridging, or OTC/consumer product pathways is advantageous given the Rx and Consumer pipeline.
Working knowledge of pharmaceutical drug development processes, ICH guidelines, and FDA/EMA clinical pharmacology expectations, including ophthalmic-specific guidance.
Proficiency with modeling and simulation tools (e.g., NONMEM, Phoenix WinNonlin/NLME, Monolix, R, Simcyp, GastroPlus).
Communicates openly and honestly with all colleagues.
Connects unrelated concepts and generates original or unique ideas.
Influences colleagues to achieve cross-functional alignment.
Manages conflict and difficult conversations in a constructive, transparent way.
Expert in industry best practices & trends with the ability to drive change.
Exceptional influencing, partnership, and collaboration skills to solve scientific and business problems and drive results.
Experience in the selection and oversight of vendors.
Knowledge of the cGMP practices and compliance requirements.
Excellent written, presentation, and verbal communication skills.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

Ophthalmic drug development, topical/ocular PK, or ocular pharmacology experience is strongly preferred.

Responsibilities

Leads clinical pharmacology, PK, PD, and pharmacometrics activities across multiple programs spanning the Rx ophthalmic pipeline (e.g., dry eye, glaucoma, retinal disease, ocular surface disease) and consumer eye health pipeline.
Contributes to action plans that best meet drug development business objectives, including candidate selection, first-in-human strategy, dose selection and justification, special population strategy, and life-cycle management.
Provides overall clinical pharmacology timelines and deliverables to inform portfolio prioritization and resourcing decisions.
Negotiates with other functional areas on project outcomes and deliverables to balance conflicting demands of time, cost, and quality/performance.
Contributes to development of departmental goals and influences strategic PK/PD decisions for the department.
Evaluates technical and scientific aspects of projects, including ocular and systemic PK, ocular bioavailability and distribution, PK/PD modeling, exposure–response analysis, population PK, PBPK, and quantitative systems pharmacology where applicable.
Designs and oversees nonclinical PK, TK and clinical pharmacology studies, including first-in-human, ocular PK, drug–drug interaction, QT/QTc, hepatic/renal impairment, pediatric, and bioequivalence/bridging studies relevant to ophthalmic products.
Applies scientific expertise to interpret clinical and nonclinical data and clearly communicates implications to management, including go/no-go recommendations.
Maintains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software (e.g., NONMEM, Monolix, Phoenix WinNonlin/NLME, R, Simcyp, GastroPlus, MATLAB).
Reviews study protocols and reports including for regulatory filings and anticipates regulatory questions.
Leads authoring of pharmacokinetics and clinical pharmacology sections of regulatory documents including IND/CTA, IB, briefing packages, pre-IND/EOP2/pre-NDA meeting materials, NDA/BLA/MAA/505(b)(2), DMFs, and periodic safety updates.
Leads responses to health authority questions and represents Pharmacokinetics and Clinical Pharmacology in agency interactions.
Ensures alignment with ICH, FDA, EMA, and other applicable guidance for ophthalmic and systemic products.
Identifies issues and supports issue resolution; conducts risk assessments and helps develop contingency plans; assures projects remain aligned with strategic objectives.
Provides scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical development decisions.
Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship.
May conduct due diligence assessments for in-licensing, acquisition, and partnership opportunities; summarizes pharmacokinetic and clinical pharmacology findings and represents the function on due diligence teams.
Communicates and presents key pharmacokinetics and clinical pharmacology information and strategy to management, regulatory agencies, external peers, scientific advisory boards, and KOLs.