Indivior
Director, Quantitative Clinical Pharmacology
Indivior, Richmond, Virginia, United States, 23214
TITLE:Director, Quantitative Clinical PharmacologyReports To:
Head, Quantitative Clinical Pharmacology, Modeling & SimulationLocation:
Richmond, VirginiaIndivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD.POSITION SUMMARY:The Quantitative Clinical Pharmacology Department plays a critical role in preclinical and clinical development, with major input in drug development strategy, study design, dose selection, and working with cross-functional teams and experts in the field to build cutting-edge science for the treatment of substance use disorders. A qualified candidate will be a highly motivated individual who will be responsible for leading quantitative clinical pharmacology activities on dedicated projects at all stages of drug development. The role will focus on providing pharmacokinetic (PK)/pharmacodynamic (PD) expertise, oversight, and strategic leadership.ESSENTIAL FUNCTIONS:The responsibilities of this job include, but are not limited to, the following:Provide strategic leadership and demonstrate accountability for quantitative clinical pharmacology programs supporting Phase 1-4 clinical development on dedicated projects.Present and defend quantitative clinical pharmacology plans and results to cross-functional project teams, internal governance committees, and regulatory agencies.Conduct or oversee the development of mathematical and statistical models (e.g., population PK and PK/PD analyses) to understand, characterize, and predict drug PK, dose-response relationships, and support dosing recommendations for special populations.Conduct meta-analyses where appropriate to maximize the use of clinical data and perform simulation studies to optimize the design and performance of future clinical trials.Support overall translational research strategy by developing preclinical and translational PK/PD models to help predict human dose range, and by supporting the development of biomarkers.Design, analyze, interpret, and report nonclinical and clinical pharmacology studies.Provide critical input into clinical study protocols and reports, modeling analysis plans, clinical investigator brochures, and regulatory submission packages.Provide oversight to CROs or consultants to ensure that high-quality work is performed within the established timelines.Contribute to the continuous improvement of M&S capability by evaluating and incorporating new M&S tools and learning/applying new M&S methodology.Support publication in high-quality peer-reviewed journals and present at scientific conferences.Ensure compliance with pertinent federal regulations and code of conduct.MINIMUM QUALIFICATIONS:Education:MS, MD, PharmD, or Ph.D. in pharmaceutical science, clinical pharmacology, biomedical engineering, or a related field with advanced training in quantitative clinical pharmacology and population PK/PD analyses.Experience and competencies:7+ years of experience in quantitative clinical pharmacology, including modeling and simulation, with small or large molecules, with direct or indirect industry (Pharma/CRO) experience.In-depth knowledge of PK, PK/PD principles, ADME concepts, and clinical pharmacology.In-depth knowledge and experience of common tools for quantitative clinical pharmacology such as NONMEM, R, SAS, WINNONLIN.Experience in designing, analyzing, and reporting clinical studies.Experience with regulatory interactions and responses to regulatory agencies.Excellent written and oral communication skills and ability to convey complex technical information clearly.Sound judgment and ability to critically analyze problems and provide creative solutions.Ability to work independently as well as in a team environment and build effective working relationships inside and outside the department.Experience in people management is desirable.Ability to effectively multi-task and deliver results on time.BENEFITS:Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:3 weeks’ vacation plus floating holidays and sick leave.401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay.U.S. Employee Stock Purchase Plan- 15% Discount.Comprehensive Medical, Dental, Vision, Life, and Disability coverage.Health and Dependent Care Flex Spending options.Adoption assistance.Tuition reimbursement.Leverage Concierge/personal assistance services.Voluntary benefits including Legal, Pet Insurance, and Auto/Home coverage.Gym, fitness facility, and cell phone discounts.Our Guiding Principles, Core Values, and Vision provide a culture that unites and guides our employees.EQUAL EMPLOYMENT OPPORTUNITY:EOE/Minorities/Females/Vet/Disabled
#J-18808-Ljbffr
Head, Quantitative Clinical Pharmacology, Modeling & SimulationLocation:
Richmond, VirginiaIndivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD.POSITION SUMMARY:The Quantitative Clinical Pharmacology Department plays a critical role in preclinical and clinical development, with major input in drug development strategy, study design, dose selection, and working with cross-functional teams and experts in the field to build cutting-edge science for the treatment of substance use disorders. A qualified candidate will be a highly motivated individual who will be responsible for leading quantitative clinical pharmacology activities on dedicated projects at all stages of drug development. The role will focus on providing pharmacokinetic (PK)/pharmacodynamic (PD) expertise, oversight, and strategic leadership.ESSENTIAL FUNCTIONS:The responsibilities of this job include, but are not limited to, the following:Provide strategic leadership and demonstrate accountability for quantitative clinical pharmacology programs supporting Phase 1-4 clinical development on dedicated projects.Present and defend quantitative clinical pharmacology plans and results to cross-functional project teams, internal governance committees, and regulatory agencies.Conduct or oversee the development of mathematical and statistical models (e.g., population PK and PK/PD analyses) to understand, characterize, and predict drug PK, dose-response relationships, and support dosing recommendations for special populations.Conduct meta-analyses where appropriate to maximize the use of clinical data and perform simulation studies to optimize the design and performance of future clinical trials.Support overall translational research strategy by developing preclinical and translational PK/PD models to help predict human dose range, and by supporting the development of biomarkers.Design, analyze, interpret, and report nonclinical and clinical pharmacology studies.Provide critical input into clinical study protocols and reports, modeling analysis plans, clinical investigator brochures, and regulatory submission packages.Provide oversight to CROs or consultants to ensure that high-quality work is performed within the established timelines.Contribute to the continuous improvement of M&S capability by evaluating and incorporating new M&S tools and learning/applying new M&S methodology.Support publication in high-quality peer-reviewed journals and present at scientific conferences.Ensure compliance with pertinent federal regulations and code of conduct.MINIMUM QUALIFICATIONS:Education:MS, MD, PharmD, or Ph.D. in pharmaceutical science, clinical pharmacology, biomedical engineering, or a related field with advanced training in quantitative clinical pharmacology and population PK/PD analyses.Experience and competencies:7+ years of experience in quantitative clinical pharmacology, including modeling and simulation, with small or large molecules, with direct or indirect industry (Pharma/CRO) experience.In-depth knowledge of PK, PK/PD principles, ADME concepts, and clinical pharmacology.In-depth knowledge and experience of common tools for quantitative clinical pharmacology such as NONMEM, R, SAS, WINNONLIN.Experience in designing, analyzing, and reporting clinical studies.Experience with regulatory interactions and responses to regulatory agencies.Excellent written and oral communication skills and ability to convey complex technical information clearly.Sound judgment and ability to critically analyze problems and provide creative solutions.Ability to work independently as well as in a team environment and build effective working relationships inside and outside the department.Experience in people management is desirable.Ability to effectively multi-task and deliver results on time.BENEFITS:Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:3 weeks’ vacation plus floating holidays and sick leave.401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay.U.S. Employee Stock Purchase Plan- 15% Discount.Comprehensive Medical, Dental, Vision, Life, and Disability coverage.Health and Dependent Care Flex Spending options.Adoption assistance.Tuition reimbursement.Leverage Concierge/personal assistance services.Voluntary benefits including Legal, Pet Insurance, and Auto/Home coverage.Gym, fitness facility, and cell phone discounts.Our Guiding Principles, Core Values, and Vision provide a culture that unites and guides our employees.EQUAL EMPLOYMENT OPPORTUNITY:EOE/Minorities/Females/Vet/Disabled
#J-18808-Ljbffr