Johnson & Johnson Careers

Clinical Pharmacology Leader - Clinical Pharmacology & Pharmacometrics (CPPM)

New Brunswick, New Jersey
Pharmacokinetics


Job Description

Requisition ID: 5378180628

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting a Clinical Pharmacology Leader - Clinical Pharmacology & Pharmacometrics (CPPM) - to be located in New Brunswick, NJ, Springhouse, PA, Titusville, NJ, Skillman, NJ or Raritan, NJ.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

The Clinical Pharmacology Leader will have responsibility of overseeing the Clinical Pharmacology activities for a unique drug development program that will be performed under a BARDA government contract. The BARDA contract is for the development of the drug as a radiation and chemical countermeasure as well as an Oncology drug for treatment of patients with Hepatocellular Carcinoma and patients with hematologic malignancies undergoing allogeneic bone marrow transplant. This individual will provide functional input into the overall project strategy and product development plans by working in close partnership with other functional leaders. The Clinical Pharmacology Leader will be accountable for overseeing external modeling teams performing PK/PD and Quantitative systems pharmacology modeling work to support clinical trial designs, analysis and registration of the drug.

The Clinical Pharmacology Leader must have extensive experience in clinical pharmacology and possess a strong understanding of application of Modeling & Simulation (M&S) in drug development. The person in this position is expected to drive innovation in clinical pharmacology and model-based drug development approaches, and to work in close collaboration with the cross-functional team.


Responsibilities:

• Ensures optimal integrated CPPM strategies for the project that embodies principles of model-based drug development. 

• Ensures the delivery of high quality CPPM plans and the contribution to clinical trial designs, protocols, reports, regulatory documents, manuscripts and presentations in partnership with the team.

• Responsible for the functional approval of CP protocols, reports and regulatory documents.

• Have direct responsibility and oversight for the external PK/PD and Quantitative Systems Pharmacology Teams. 

• Ensure effective and credo-based performance management of external vendors in compliance with applicable regulations and company policies.

Qualifications

• A minimum of a PhD in (clinical) pharmacology, pharmacometrics, or equivalent.

• A minimum of 10 years of industry related experience is required. 

• Demonstrated experience in the field of clinical pharmacology and pharmacometrics is required.

• In-depth understanding of clinical drug development is required.

• In-depth understanding of the overall pharmaceutical R&D process is required.

• In-depth understanding of the overall compound development strategy from pre-NME to submission and post-submission is required.

• Experience with coordination of IND/NDA/MAA/CTD filings and interacting with regulatory authorities is preferred.

• Broad understanding of disease area, patient populations, pathology/pathophysiology, and medical practices relevant to Oncology is preferred.

• Comprehensive understanding of regulatory health authority guidelines, processes and systems related to major markets (US, Europe, Japan, others) is required.

• Thorough understanding of or experience with the use of model based approaches, applicable to CPPM in general is required. 

• Functional proficiency in the use of diverse PK/ADME software tools and the MS suite of software products is preferred.

• Excellent oral and written communication skills are required.

• This position requires up to 20% travel, both domestic and international.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-New Jersey-New Brunswick
Organization
Johnson & Johnson (6067)
Job Function
Pharmacokinetics
Requisition ID
5378180628