Senior Principal Scientist, Clinical Pharmacology and Pharmacometrics - Johnson and Johnson

Johnson & Johnson Innovative Medicine is recruiting for a Senior Principal Scientist, Clinical Pharmacology and Pharmacometrics, located in Spring House, PA or Raritan, NJ. Remote work options within the US may be considered on a case-by-case basis.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Therapeutic Area (TA) Clinical Pharmacology (CP) Senior Principal Scientist role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology components of simple and complex clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of principles of model-informed drug development (MIDD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support. The Senior Principal Scientist CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound, including interactions with regulatory agencies and functions as CPP Leader on the Compound Development Teams (CDT). The Senior Principal Scientist CPP leader can independently drive the clinical pharmacology aspects of the assigned programs and may provide management directly or indirectly to junior CPP leaders.

Key Responsibilities:

• Developing and executing CP development strategy in supporting the selection of the right dose-regimen, in the right population, using the relevant biomarkers and the right endpoint to achieve differentiation and develop a CP package that enables global product registration.
• Accountable for all CP trial design, analysis of data, reporting and interpretation of results.
• Design and execution of appropriate modeling plans along with the Pharmacometric scientist assigned to the project.
• Conducting hands-on pharmacokinetic and pharmacokinetic-pharmacodynamic analysis for drug development projects.
• Contribute to the required components of regulatory submissions and be responsible for responding to regulatory authority queries.
• Provide mentorship to CP colleagues on hands-on aspects of clinical pharmacology.
• Drive early alignment on key development questions where CP principles could be applied.
• Attend governance meetings, as necessary, ensure that CP plans are flawlessly executed, on time for efficient decision making.
• Lead the integration of input from all relevant functions as well as the preferred sourcing partners to formulate an efficient execution plan.
• Ensure access to optimum capabilities including resourcing for CP studies, developing sustainable strategy to acquire or develop internally all necessary CP techniques that are aligned with the disease area of interest to Janssen R&D.
• Acquire or develop internally, tools and training to enable identification and development of question-based drug development opportunities.

Education:

• PhD (or equivalent experience) in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 6 years of experience in pharmaceutical or related field (or relevant experience).

Experience and Skills:

Required:

• Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.
• Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab).
• Demonstrated understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process Demonstrated ability to apply innovative tools to enable rational and efficient clinical pharmacology strategy of the drug development plan.
• Drug development experience in the therapeutic area of interest including understanding of disease, patient population, and treatment paradigm.
• Working knowledge of US, European, and Asian regulatory requirements and guidelines.
• Good oral and written communication skills, including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively.
• Has established a strong level of expertise and scientific reputation through multiple publications and presentations.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]

The anticipated base pay range for this position is 135000 to 232300.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.