Reports To: Head, Quantitative Clinical Pharmacology, Modeling & Simulation
Location: Remote
Indivior 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. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.
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. He or she will represent the clinical pharmacology discipline on multidisciplinary teams, including governance committees, to support the design of an efficient clinical development program and robust registration package.
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, disease progression 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 predicting human dose range, and by supporting the development of biomarkers
Design, analyse, 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, analysing 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 judgement and ability to critically analyse problems and provide creative solutions
Ability to work independently as well as in a team environment and build effective working relationships inside and outside 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.
GUIDING PRINCIPLES:
Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
COMPLIANCE OBLIGATIONS:
Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:
Employee Obligations:
Always act with honesty and integrity.
Risk IQ: Know what policies apply to your role and function and adhere to them.
Speak Up: If you see something, say something.
Manager Obligations:
Always act with honesty and integrity
Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
Model and reinforce a Speak Up culture on your team.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
