Director, Clinical Pharmacology & Pharmacometrics (CPP) - Johnson and Johnson

Johnson & Johnson is recruiting for a Director, Clinical Pharmacology & Pharmacometrics (CPP) located in Raritan, NJ; Spring House, PA or La Jolla, CA.

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 Director role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology components of 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 Director, CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound including innovative ways and leads the regulatory strategy for clinical pharmacology. As CPP Leader on the Compound Development Teams (CDT), the Director works in collaboration with various partners within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics) and provides recommendations that impact the drug development decisions for a program in addition to independently complete the day to day operations for the clinical pharmacology aspects of one or more programs within a disease area and provide management directly or indirectly to junior CPP leaders. The Director CPP leader contributes to the strategic direction of CPP department and/or TA.

Key Responsibilities:

• Responsible for the planning and execution of the clinical pharmacology and model informed drug development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support patient sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.
• Translate quantitative knowledge into strategic opportunities with key partners to drive development along the model-informed drug development principles.
• Plan, perform, and/or provide oversight forappropriate analyses of preclinical-clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design and overall drug development strategy.
• Responsible for planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
• Accountable for planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates and TA strategy.
• Introduce new approaches to problem-solving, process enhancements, and improvement of efficiencies.
• Manage directly or indirectly more junior CPP colleagues.
• Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
• Plan, conduct, and/or provide oversight of PK and PK/PD analyses and reporting
• Devise clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches.
• Manage and/or supervise operational elements of CPP studies.
• Develop key product differentiation strategies based on a compound's key attributes and relevant therapeutic landscape.
• Define regulatory strategy for CP and prepare CP contributions to regulatory documents including IBs, IND's, briefing books, submission packages, responses to health authority questions, and other regulatory documents.
• Represent CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
• Participate in the evaluation of potential business development opportunities.
• Stay abreast of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and identify new opportunities for applied scientific and technical advancement within the department.
• Influence external scientific and/or regulatory environment by establishing strong interactions with opinion leaders beyond Janssen R&D and developing external collaborations with relevant professional organizations or consortium.
• Develop expertise in relevant TA including understand of pathophysiology including relevant pathway, patient population, competitive landscape, relevant endpoints.
• Develop relationships and influence partners (e.g., TA, regulatory, and other colleagues).
• Work effectively in a matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
• Apply appropriate regulatory (e.g., FDA, EMA, ICH etc) guidelines in the design of clinical development plans and studies.
• Foster working environment that promotes collaboration, innovation, and creativity.
• Assist in process improvement initiatives and SOP development where applicable.
• Attend governance and advisory meetings representing CP function, as necessary, ensure that CP plans are flawlessly implemented, on time for efficient decision making.
• Provide and arrange training and presentations on innovative CP approaches across the R&D organization, ensuring awareness and adequate knowledge about CPP capabilities and expertise within the TA and QS.
• Participating in program committees, coordinating sessions, presenting at scientific meetings, and publishing in peer reviewed journals.

Education:

• A minimum of a Bachelor's degree is required. An advanced degree (PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences) is preferred.

Experience and Skills:
Required:

• 10 years of experience in pharmaceutical or related fields 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.
• Demonstrated experience and capability in development of and aiding decisions with model-based approaches is required.
• Extensive drug development experience in one or multiple therapeutic areas including understanding of disease, patient population, and treatment paradigms is required.
• Excellent communication skills, leading meetings and interacting with team members, collaborators, and regulatory authorities is required.
• Thorough understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process is required.
• Demonstrated ability to apply innovative tools to enable rational and efficient clinical pharmacology and drug development strategy is required.
• Detailed understanding of US, European, and Asian regulatory requirements and guidelines is required.

Preferred:

• Outstanding leadership and ability to mentor junior colleagues, exemplified through the ability to inspire others, to set a positive example by providing assistance, recognition and encouragement is preferred.
• Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab) is preferred.
• Has established a strong level of expertise and scientific reputation through multiple publications and presentations is preferred.

The anticipated base pay range for this position is $157,000 to $271,400.

California Bay Area - The anticipated base pay range for this position is $193,000 to $312,110.

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)).
• This position is eligible to participate in the Company's long-term incentive program.
• 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.

This job posting is anticipated to close on 10/16/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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 .