Associate Director, Clinical Pharmacology

Jobtailor; Connecticut; On-site; USD 150,000 - 210,000; Full time

Job summary

Jobtailor in the United States seeks a senior Clinical Pharmacology expert to lead cross-functional teams on PK/PD programs, develop clinical pharmacology plans, and drive regulatory submissions.

You will design model-informed drug discovery and development plans, implement predictive models, and guide dose-ranging strategies while collaborating across disciplines and mentoring colleagues.

Qualifications

• M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or a related discipline
• 5+ years of industry experience in clinical pharmacology and/or PK/PD and/or pharmacometrics/systems pharmacology
• Strong quantitative skills and expertise in mechanistic PK/PD modeling, population modeling, and clinical trial simulations
• Experience using NONMEM, R, or similar tools
• Excellent written and verbal communication skills
• Ability to attend global meetings across time zones

Responsibilities

• Act as Clinical Pharmacology representative on sub teams and development teams
• Provide clinical pharmacology expertise, leadership, and project deliverables
• Design and execute clinical pharmacology plans and implement best practices
• Collaborate with other disciplines to establish preclinical PK/PD knowledge and predictive models
• Plan and oversee project-level clinical pharmacology activities including CP plans and PK/PD strategies
• Plan and oversee study-level activities including protocol authoring and reporting
• Ensure appropriate dose-range finding strategies and optimize doses
• Design and implement end-to-end model-informed drug discovery and development plans
• Use innovative analytical methods to integrate PK, PD, patient, and disease knowledge
• Contribute to regulatory documents such as briefing documents and regulatory queries
• Develop new methodologies through collaborations
• Coach less experienced colleagues
• Monitor literature, guidelines, and SOPs
• Influence the external environment through publications and presentations

Skills

Pharmacokinetics

Pharmacometrics

Clinical Pharmacology

Mechanistic PK/PD Modeling

Population Modeling

Clinical Trial Simulations

Dose-Range Finding Strategies

Analytical Methods Integration

Protocol Authoring

Biomarker Strategies

Education

MD/PhD/PharmD

Pharmacokinetics/Pharmacometrics training

Tools

NONMEM

R

Job description

• Act as Clinical Pharmacology representative on Clinical Sub Teams, Development Teams, and other multifunctional teams


• Provide clinical pharmacology expertise, leadership, and project deliverables


• Design and execute clinical pharmacology plans and implement best practices


• Collaborate with other disciplines to establish preclinical PK/PD knowledge and predictive models before first-in-human studies


• Plan and oversee project-level clinical pharmacology activities, including clinical development plans and PK/PD, immunogenicity, and biomarker strategies


• Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting


• Ensure appropriate dose-range finding strategies and optimize doses and dosage regimens


• Design and implement end-to-end model-informed drug discovery and development plans


• Use innovative analytical methods to integrate PK, PD, patient, and disease knowledge


• Contribute to regulatory documents, including briefing documents, regulatory queries, Investigator’s Brochures, INDs, and NDA/MAAs


• Develop new methodologies through internal and external collaborations


• Coach less experienced colleagues and team members


• Monitor literature, regulatory guidelines, internal guidance, and SOPs


• Influence the external environment through publications, presentations, scientific societies, and industry consortia

Requirements

• M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or a related discipline


• 1+ year of industry experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics/systems pharmacology


• Pharm.D. or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or a related discipline


• 5+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics/systems pharmacology


• Strong quantitative skills and expertise in mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations


• Experience using NONMEM, R, or similar tools


• Intimate knowledge of drug development and quantitative pharmacology approaches to knowledge integration


• Excellent written and verbal communication skills


• Demonstrated presentation skills


• Ability to attend global meetings periodically across different time zones


• Candidates must be authorized to be employed in the U.S. by any employer


• Permanent work authorization in the United States required


• U.S. work visa sponsorship is not available now or in the future

Demonstrates expertise in clinical pharmacology, including pharmacokinetics and pharmacometrics, with a strong focus on model-informed drug discovery and development. Proven ability to lead cross-functional teams and contribute to regulatory submissions while ensuring compliance with industry standards.

Highest-signal resume keywords

• Clinical Pharmacology Expertise


• Pharmacokinetics Modeling


• NONMEM Proficiency


• Regulatory Document Contribution


• Quantitative Skills

ATS Optimization Keywords

Hard Skills

• Pharmacokinetics


• Pharmacometrics


• Clinical Pharmacology


• Mechanistic PK/PD Modeling


• Population Modeling


• Clinical Trial Simulations


• Dose-Range Finding Strategies


• Analytical Methods Integration


• Protocol Authoring


• Biomarker Strategies

Soft Skills

• Excellent Communication Skills


• Presentation Skills


• Coaching and Mentoring

Certifications & Qualifications

• M.D.


• Ph.D.


• Pharm.D.

Industry Keywords

• Clinical Development Plans


• PK/PD


• Immunogenicity


• Biomarker Strategies


• Regulatory Guidelines


• SOPs


• First-in-Human Studies


• Global Meetings

Tools & Technologies

• NONMEM


• R