Director, Quantitative Clinical Pharmacology

7+ years

Not Disclosed

Remote

10 Sept. 19, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director, Quantitative Clinical Pharmacology

Reports To: Head, Quantitative Clinical Pharmacology, Modeling & Simulation
Location: Remote

About Indivior

Indivior is a global specialty pharmaceutical company dedicated to transforming the lives of individuals struggling with substance use disorders (SUD) and serious mental illnesses. Our name combines "individual" and "endeavor," reflecting our commitment to each patient’s unique journey toward recovery. Our vision is to turn addiction from a global crisis into a recognized chronic disease, ensuring that patients everywhere have access to evidence-based treatment.

With a strong portfolio in opioid use disorder, we are expanding our pipeline to address other chronic conditions and co-occurring disorders, including alcohol and cannabis use disorders.

Position Summary

The Quantitative Clinical Pharmacology Department is integral to our preclinical and clinical development efforts. We focus on drug development strategy, study design, and dose selection while collaborating with cross-functional teams. We seek a highly motivated Director to lead quantitative clinical pharmacology activities across all stages of drug development, emphasizing pharmacokinetics (PK) and pharmacodynamics (PD). You will represent the clinical pharmacology discipline on multidisciplinary teams to design efficient clinical development programs and robust registration packages.

Essential Functions

Key responsibilities include:

Provide strategic leadership and accountability for quantitative clinical pharmacology programs supporting Phase 1-4 clinical development projects.
Present and defend quantitative clinical pharmacology plans and results to cross-functional teams, governance committees, and regulatory agencies.
Develop and oversee mathematical and statistical models (e.g., population PK and PK/PD analyses) to predict drug behavior, dose-response relationships, and dosing recommendations for special populations.
Conduct meta-analyses and simulation studies to optimize future clinical trial design and performance.
Support translational research by developing preclinical and translational PK/PD models for predicting human dosing ranges and supporting biomarker development.
Design, analyze, interpret, and report nonclinical and clinical pharmacology studies.
Provide critical input into clinical study protocols, analysis plans, investigator brochures, and regulatory submissions.
Oversee CROs and consultants to ensure high-quality work is completed on time.
Contribute to the continuous improvement of modeling and simulation capabilities by evaluating and adopting new tools and methodologies.
Support publications in peer-reviewed journals and present findings at scientific conferences.
Ensure compliance with federal regulations and ethical standards.

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 for small or large molecules, with direct or indirect industry experience (Pharma/CRO).
In-depth knowledge of PK, PK/PD principles, and ADME concepts.
Proficiency with common tools in quantitative clinical pharmacology, such as NONMEM, R, SAS, and WINNONLIN.
Experience in designing, analyzing, and reporting clinical studies.
Familiarity with regulatory interactions and responses.
Excellent written and verbal communication skills, with the ability to convey complex technical information clearly.
Strong analytical skills and sound judgment in problem-solving.
Ability to work independently and collaboratively, fostering effective working relationships.
Experience in people management is a plus.
Proven ability to multi-task and deliver results on schedule.

Benefits

Indivior offers a comprehensive benefits package that reflects our commitment to our employees, including:

3 weeks of vacation plus floating holidays and sick leave
401(k) and Profit Sharing Plan with a company match of 75% on your first 6% of contributions and a profit-sharing contribution equal to 4% of eligible pay
U.S. Employee Stock Purchase Plan with a 15% discount
Comprehensive Medical, Dental, Vision, Life, and Disability coverage
Health and Dependent Care Flex Spending options
Adoption assistance and tuition reimbursement
Concierge/personal assistance services
Voluntary benefits, including Legal, Pet Insurance, and Auto/Home coverage
Discounts for gym, fitness facilities, and cell phones

Our guiding principles and core values foster a culture that unites and inspires our employees.

Compliance Obligations

Indivior prioritizes compliance and encourages employees to report potential policy violations or unethical behavior. As part of your responsibilities, you are expected to:

Employee Obligations:

Act with honesty and integrity.
Know and adhere to relevant policies.
Speak up if you see something concerning.

Manager Obligations:

Model honesty and integrity.
Promote risk awareness and accountability within your team.
Encourage a culture of open communication.

Equal Employment Opportunity

Indivior is an Equal Opportunity Employer and welcomes applications from all qualified candidates, including minorities, females, veterans, and individuals with disabilities.

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