Director, Clinical Pharmacology

Johnson & Johnson Innovative Medicine•San Diego, CA

1d•$168,000 - $290,950•Onsite

About The Position

Johnson & Johnson is seeking a Director, Clinical Pharmacology for its Clinical Pharmacology & Pharmacometrics (CPP) organization, based in Raritan, New Jersey; Titusville, New Jersey; Spring House, Pennsylvania; or La Jolla, California. The role applies and promotes clinical pharmacology expertise across drug development, including the design of clinical pharmacology studies and clinical pharmacology components of other studies, pharmacokinetic (PK) and pharmacodynamic (PD) analysis and reporting, and model-informed drug development (MIDD). The scope ranges from pre-New Molecular Entity declaration through post-marketing support. The Director develops or oversees compound-specific clinical pharmacology strategy and leads the associated regulatory strategy. As the clinical pharmacology leader on Compound Development Teams, the Director collaborates with cross-functional partners, provides recommendations that influence development decisions, and independently manages day-to-day clinical pharmacology activities for one or more programs. The role also manages and guides CPP colleagues, contributes to the department’s strategic direction, and advocates for innovative approaches. The Director plans and oversees quantitative analyses and strategies that integrate nonclinical and clinical data to guide development decisions, patient sub-population selection, dose and regimen selection, and study design. Responsibilities include regulatory input and representation, oversight of study operations and regulatory documents, product differentiation, business development evaluations, and contributions to scientific advancement and external collaborations. Up to 5% domestic or international travel may be required.

Requirements

PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or a relevant biological science.
At least 10 years of pharmaceutical industry experience.
Expert knowledge of PK, PD, PK-PD, and/or Translational Medicine and their application in MIDD.
Understanding of advanced analysis methods such as population analysis, PBPK, and QSP, and modeling tools such as NONMEM, R, GastroPlus, Simcyp, WinNonlin, and MATLAB.
Detailed understanding of drug development, MIDD, and the pharmaceutical R&D process.
Drug development experience in one or more therapeutic areas, including understanding of disease, patient populations, and treatment paradigms.
Detailed understanding of US, European, and Asian regulatory requirements and guidelines.
Excellent communication skills, including leading meetings and interacting with team members, collaborators, and regulatory authorities.
Experience leading a team, developing talent, and providing feedback, coaching, and career development to direct reports.
Outstanding leadership and ability to mentor junior colleagues, inspire others, and set a positive example through assistance, recognition, and encouragement.
Ability to travel domestically or internationally up to 5%.

Nice To Haves

Established scientific expertise and reputation demonstrated through multiple publications and presentations.

Responsibilities

Develop and oversee compound-specific clinical pharmacology strategies, including innovative approaches, across development programs.
Plan and oversee clinical pharmacology and MIDD strategies, applying quantitative methods to integrate nonclinical data, PK, PD, patient characteristics, disease states, competitive landscape, and drug interactions.
Translate quantitative knowledge into strategic opportunities with partners and advocate for development guided by MIDD principles.
Plan, conduct, interpret, and oversee analyses such as non-compartmental, population, and modeling and simulation analyses of PK and PD data to guide dose regimens, study design, and development strategy.
Provide clinical pharmacology regulatory input, including strategy, regulatory interactions, labeling, and clinical use.
Plan and deliver scientifically robust and efficient clinical pharmacology strategies for development candidates, potentially across multiple programs within a disease area.
Represent CPP in cross-functional teams, initiatives, and review or governance meetings; introduce problem-solving approaches and process improvements.
Manage a team of CPP colleagues and provide oversight, guidance, mentorship, feedback, and career development.
Carry out responsibilities in accordance with applicable SOPs, regulatory requirements, and Johnson & Johnson Credo principles.
Plan, conduct, or oversee PK and PK/PD analyses and reporting.
Design Phase I clinical pharmacology studies or use alternate modeling approaches consistent with regulatory guidelines.
Manage or supervise operational elements of CPP studies.
Develop product differentiation strategies based on compound attributes and the therapeutic landscape.
Define CPP regulatory strategy and oversee clinical pharmacology contributions to investigator brochures, INDs, briefing books, submission packages, responses to health authority questions, and other regulatory documents.
Represent clinical pharmacology in external regulatory meetings, including End of Phase 2, pre-NDA/MAA, and Advisory Committee meetings.
Participate in evaluating potential business development opportunities and provide recommendations.
Advance clinical pharmacology, MIDD, analytical methodology, and drug development knowledge through scientific engagement, publications, presentations, professional societies, and identification of scientific and technical opportunities.
Influence the external scientific and regulatory environment by engaging opinion leaders and developing external collaborations with professional organizations or consortiums.
Develop therapeutic-area expertise, including knowledge of pathophysiology, relevant pathways, patient populations, competitive landscapes, and endpoints.
Build relationships with and influence therapeutic-area, regulatory, and other partners.
Ensure clinical pharmacology deliverables meet timelines and overall project goals.

Benefits

Company consolidated retirement plan (pension)
401(k) savings plan
Long-term incentive program
Vacation: 120 hours per calendar year
Sick time: 40 hours per calendar year, with specified higher allowances for employees residing in Colorado or Washington
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 a birth, adoption, or foster care placement
Bereavement leave
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