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Director, Clinical Pharmacology
Johnson & Johnson. Develop and/or oversee compound-specific Clinical Pharmacology strategy across all stages of development .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Pharmacology strategy, including PK, PD, and model-informed drug development principles. Proven ability to lead cross-functional teams, mentor colleagues, and ensure compliance with regulatory requirements.
Highest-signal resume keywords
PhD In Pharmaceutical Sciences10+ Years Experience In Pharmaceutical IndustryExpert Knowledge Of PK, PD, PK-PDAdvanced Analysis Methods (Population Analysis, PBPK, QSP)Leadership And Team Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Pharmacology Strategy DevelopmentClinical Study DesignNon-Compartmental AnalysisPopulation ModelingSimulation AnalysisDrug Development Process UnderstandingRegulatory Document PreparationTherapeutic Area ExpertiseProduct Differentiation StrategiesScientific Publication And Presentation
Soft Skills
Excellent Communication SkillsMentoring And CoachingTeam LeadershipCollaborationInterpersonal Skills
Tools & Technologies
NONMEMRGastroplusSimcypWinnonlinMatlab
Industry Keywords
Clinical PharmacologyTranslational MedicineModel Informed Drug Development (MIDD)Regulatory RequirementsPharmaceutical R&D ProcessTherapeutic LandscapeDrug InteractionsPatient Population UnderstandingSOP ComplianceBusiness Development Opportunities
About the role
Key responsibilities & impact- Develop and/or oversee compound-specific Clinical Pharmacology strategy across all stages of development
- Lead clinical pharmacology strategy on Compound Development Teams and provide recommendations affecting drug development decisions
- Design clinical pharmacology studies and clinical pharmacology components of clinical studies
- Apply PK, PD, PK-PD, translational medicine, and model-informed drug development principles
- Integrate nonclinical data, PK/PD, patient characteristics, disease states, competitive landscape, and drug interactions to support go/no-go decisions, dose selection, patient sub-population support, and study design
- Plan, conduct, interpret, and oversee non-compartmental, population, modeling, and simulation analyses
- Provide regulatory input for clinical pharmacology strategy, interactions, labeling, clinical use, and regulatory documents
- Represent Clinical Pharmacology and Pharmacometrics in cross-functional teams, initiatives, governance meetings, and external regulatory meetings
- Manage a team of CPP colleagues and provide oversight, guidance, mentoring, and career development
- Supervise operational elements of CPP studies and ensure compliance with SOPs, regulations, and Johnson & Johnson Credo principles
- Develop product differentiation strategies based on compound attributes and therapeutic landscape
- Evaluate business development opportunities and provide recommendations
- Contribute to scientific and technical advancement through publications, presentations, professional societies, external collaborations, and industry engagement
- Develop therapeutic area expertise and relationships with internal and external partners
- Ensure accountability for Clinical Pharmacology deliverables, timelines, and project goals
Requirements
What you’ll need- A PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences is required
- 10+ years of experience in the pharmaceutical industry is required
- Expert knowledge and understanding of PK, PD, PK-PD, and/or Translational Medicine and their applications in model informed drug development (MIDD) is required
- Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab) is required
- Detailed understanding of overall process of drug development including MIDD and the overall pharmaceutical R&D process is required
- Drug development experience in one or multiple therapeutic areas, including understanding of disease, patient population, and treatment paradigms, is required
- Detailed understanding of US, European, and Asian regulatory requirements and guidelines is required
- Excellent communication skills, leading meetings and interacting with team members, collaborators, and regulatory authorities, is required
- Experience leading a team, developing talent, and providing feedback, coaching, and career development to direct reports is required
- Outstanding leadership and ability to mentor junior colleagues is required
- Strong level of expertise and scientific reputation through multiple publications and presentations is preferred
- Up to 5% international or domestic travel may be required
Benefits
Comp & perks- Company consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Inclusive interview process accommodations
- Up to 5% international or domestic travel may be required