& 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
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
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.
- 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
United States-New Jersey-RaritanOther Locations
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research non-MDRequisition ID