Scientific Director-Preclinical Development Leader Pharmacokinetics, Dynamics and Metabolism (PCDL) - San Diego, CA | Biospace
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Scientific Director-Preclinical Development Leader Pharmacokinetics, Dynamics and Metabolism (PCDL)

Johnson & Johnson Family of Companies

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Location:
San Diego, CA
Posted Date:
8/7/2017
Position Type:
Full time
Job Code:
10001631
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Development, Director, Metabolism, Pharmacokinetics, Preclinical,

Job Description


Description:

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientific Director (PCDL), located in La Jolla, CA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

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 San Diego based team of Preclinical Project Development, has an open position for an experienced PCDL with a background in pharmacokinetics (PK), metabolism and PK/PD. The PCDL will provide scientific and strategic leadership for all aspects of the non-clinical development plan for assigned products, with a focus on small molecules in late discovery, early development and including post-marketing. The PCDL represents Preclinical Development & Safety (PD&S) in Compound Development Teams (CDT) and is the interface between the CDT, PD&S functional and senior management.

The Scientific Director, (PCDL) will:

• Provide scientific and strategic leadership to projects, mainly in the therapeutic areas of Immunology and Neuroscience, with a focus on small molecules in late discovery, early and late development and occasionally post-marketing.
• Lead the development and maintenance of the PD&S strategic plan as well as the operational project plans (activities, resource requirements, budget and timelines) for assigned compounds.
• Represent PD&S in Compound Development Teams and assure optimal design and execution of nonclinical safety strategies.
• As key contributor to the selection and timely development of new compounds, work in close collaboration with therapeutic areas, CMC, clinical pharmacology, clinical and regulatory functions.
• Be responsible for the integrated Safety, PK and PK/PD assessments in close collaboration with the functional experts
• Represent PD&S at internal and external review committees, also including Global Health Authority meetings.
• Lead a preclinical subteam of functional experts to move projects forward.
Identify potential safety, PK and PK/PD related issues impacting drug development, design and implement mitigation plans and guarantee the overall quality of the project.
• Lead the preparation of regulatory documents (i.e., IND, NDA, MAA, CTD and responses to regulatory agencies) prepared by the preclinical subteam.
• Remain informed on the existing and evolving preclinical guidelines.
• Take a lead position in the preclinical review of potential in-license candidates.
• In conjunction with functional management, plan and provide developmental opportunities for preclinical subteam members to increase efficiency, encourage job satisfaction, and ensure training for potential advancement.

Requirements


Qualifications:

• A PhD degree in Pharmaceutical Sciences or Pharmacology or proven equal experience, with a strong understanding of ADME processes and PK/PD, and general knowledge of the functional disciplines within PD&S is required.
• A minimum of 5 years of experience as a (Pre)clinical Scientist in pharmaceutical Compound Development Teams (including preparation of functional project plans, coordination of NDA/MAA/CTD filings and interacting with regulatory authorities) is required
• A minimum of 5 years of experience of PK functional (lab-based) experience is required. (various metablolism, PK, Bioanalyis, PK/ADME ,Modeling, project experience)
• Experience in interpretation of PK properties and PK/PD data relevant to drug development is required.
• Organizational, planning, problem solving skills and the leadership skills needed in the completion of deliverables to the Compound Development Team is preferred
• Excellent partnering and decision-making skills, the ability to perform effectively in a constantly changing environment, to bring perspectives and approaches together in novel and unique ways, and create and suggest new ideas for projects/programs is preferred
• Excellent oral and written communication skills and ability to clearly and concisely present and communicate nonclinical safety results and their impact to various audiences, including internal boards, Health Authorities and investigators is preferred.
• Ability to empower people, discover and develop potential and challenge in a positive manner where necessary is preferred

Primary Location:
North America-United States-California-San Diego

Organization:
Janssen Research & Development, LLC. (6084)

Job Function:
R&D

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