Associate Scientific Director, Established Products
Location:
Spring House , Pennsylvania
Posted:
April 02, 2017
Reference:
9770170210/3-en-us

Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Associate Scientific Director, Established Products to be located in Raritan, NJ, Titusville, NJ, or Spring House, PA.

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.


We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 

The Associate Scientific Director, Established Products, is responsible for providing Clinical Pharmacology (CP) expertise including pharmacokinetics (PK), pharmacodynamics (PD) to multiple products in post-marketing.  This individual will be responsible and accountable for developing compound specific Clinical Pharmacology Development Plan (CPDP) if appropriate.  He/she will collaborate with diverse stakeholders, QS-project matrix teams and Quantitative Sciences Therapeutics Area Leaders (QS-TALs) within Clinical Pharmacology and Established Products.  This individual will independently execute the day to day operations for the clinical pharmacology aspects of the assigned programs.

 

The Associate Scientific Director, Established Products will:

  • Provide support to numerous diverse products simultaneously.  The successful candidate must be able to prioritize tasks, as appropriate, and provide deliverables on short notice and with short timelines.
  • Provide ClinPharm contribution to Established Products (EP) project teams (e.g. Compound Development teams (CDTs), Clinical Working Groups (ClinWGs), and Safety Management Teams (SMTs) and have familiarity with the clinical pharmacology and regulatory history of assigned products.
  • Ensure appropriate, accurate, and timely responses to ClinPharm-relevant questions/comments from global health authorities on assigned projects. Such responses may be generated through internal discussions (within CDT, Labeling Working Group (LWG) or Local Operating Company (LOC) or as written responses.  This includes appropriate archival of relevant documents (Clinical Overviews, relevant literature) used to develop responses to health authorities (as a historical record).
  • Ensure preparation of, or contribution to the preparation of, Clinical Overviews to support updates and revisions to core Company documents (e.g. US Package Inserts (USPIs), Summary of Product Characteristics (SPCs), Company Core Data Sheets (CCDSs), Investigator Brochures (IBs), etc.).
  • Ensure preparation of relevant submission documents for product line extensions or to support product filings for new formulations, new manufacturing sites, or in response to health authority requests.  This individual will attend health authority meetings as appropriate to support ClinPharm positions or to provide ClinPharm input as needed.
 


Qualifications
  • A Bachelor’s degree with 8 years of pharmaceutical or related work experience OR an advanced degree with 6 years of pharmaceutical or related work experience OR a Doctorate level degree (e.g. PhD, PharmD, MD, etc.) with 4 years of pharmaceutical or related work experience is required
  • Work experience in a cross-functional team environment is required
  • Effective communication skills with demonstrated ability to present Clinical Pharmacology results, interpretations and conclusions for various reports and/or audiences that are clear and concise is required
  • Demonstrated understanding of PK, PD, PK/PD, and Translational Medicine is preferred. 
  • Good understanding of clinical drug development and the overall pharmaceutical R&D process is required
  • Do you have knowledge of US, European, and Asian regulatory requirements and guidelines is required
  • Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s) is preferred. 
  • This position will be located in Raritan, NJ, Titusville, NJ, or Spring House, PA and will 10% domestic and international travel
 
Johnson –n- Johnson is an equal opportunity employer 


Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Research non-MD
Requisition ID
9770170210

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