Regional Therapeutic Area Expert - Americas
Location:
Spring House , Pennsylvania
Posted:
March 31, 2017
Reference:
3191170226/5-en-us

Janssen Research & Development LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Regional Therapeutic Area Expert - Americas (Immunology and Oncology).  This position can be located in the United States, Canada, Mexico, Argentina or Brazil.
 
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 Regional Therapeutic Area Expert - Americas will be accountable for predictability and success of feasibility to support delivery of study programs in our Immunology and Oncology areas.  The Americas region consists of Canada, United States, Mexico, Argentina and Brazil as core countries.  This individual will provide input to protocol design via Environmental Analysis (EA)/Protocol Feasibility (PF).  Ensure proper assessment of protocol and planned procedures are completed and appropriate mitigations are discussed and supported.  Provide information to countries that sets them up to better perform on trials by ensuring population and execution strategy is well-understood.  Discuss and agree upon output in regards to recruitment rate, competitive landscape, etc. and provide input and/or recommendations on investigators.  Keep countries informed on future programs and feasibilities and address key focus points and hurdles for each protocol.  Influence country selection to achieve optimal study placement for recruitment rate and partner with stakeholders (e.g. Portfolio Delivery Operations (PDO), Therapeutic Area (TA), Medical Affairs (MAF), Investigators) to analyze feasibility data.  Identify, escalate and support mitigation of delivery issues in on-going trials.  The position will report to the Regional Global Clinical Operations (GCO) Head and has a dotted reporting line to the Global Operating Head (GOH) of the respective TA.
 
Principal Duties and Responsibilities:
  • Define strategy and develop the region (based on portfolio planning) to ensure successful and efficient trial allocation execution.
  • Provide early input in protocol design from the region to optimize trial execution (recruitment, timelines, quality).
  • Develop regional strategy and support the countries in building strategic relationships with network of investigators.
  • Support finding new investigational sites, as required by TA/MAF and future clinical trial demands.
  • Build an appropriate knowledge base to execute future programs.
  • Support good training on pathology and protocol for local teams.
  • Provide regional input/represent the region in meetings and discussions on study placement/allocations (e.g. core review team meetings, working group meetings, scientific and operational review meetings, feasibility review meetings).
  • Provide PDO and TA/MAF consolidated regional input and identify elements for successful recruitment and country selection.
  • Obtain consolidated country/regional input during protocol feasibility and provide proposal for list of countries from the region for site feasibility.
  • Work with RTAEs from other regions to develop global recommendations for protocol and study placement.
  • Help design critical feasibility questions to ensure successful trial execution (recruitment and quality).
  • Define regional commitment at the time of conduct of site feasibility and be accountable for consolidated proposal of country and site selection based on feasibility outcome for the region and applying regional efficiency criteria (regulatory and market access requirements, start up timelines, recruitment speed, productivity and quality).
  • Support PDO in building up and implementing recruitment contingency for the region in an assigned study.
  • Support delivery of trial performance through mitigation activities as directed within the region. 
  • Share accountability with GCO Regional Heads for delivery of country enrollment commitments.
  • Participate in Portfolio Review meetings for the trial/region.
  • Possess a thorough knowledge of the TA landscape in the region.
  • Possess in depth understanding of the pathology and knowledge of the developments programs (strategy, positioning of the product, competitive environment, etc.).
  • Possess a good understanding of the standard of care in the region, the different health care systems and relevant local regulations, is able to assess potential impact on TA programs, reference drugs and is able to advise PDO teams and TA on the future strategy for the region.
  • Establish strong and productive relationship with PDO, the countries within the region and relevant non-GCO stakeholders e.g., MAF; and Commercial, Regulatory, Project Management Office (PMO) as required.
  • Shape the direction in a new area, and build a new organization with limited guidance.  Understand and adapt to different cultures and markets.

Qualifications
  • A minimum of a Bachelor’s Degree is required.  Advanced Degree (Master’s, MD or PhD) is preferred.
  • A minimum of 6 years of experience with clinical research is required.
  • Pharmaceutical industry experience is required.
  • Immunology and/or Oncology experience is preferred.
    Knowledge of the drug development process is required.
  • Solid knowledge of Global Clinical Procedures (GCPs) and relevant local regulations related to clinical research is required.
  • Good scientific and medical expertise enabling peer-to-peer connections with Key Opinion Leaders (KOLs) preferred.
  • Proficiency in English (reading, writing, speaking) is required.
  • Multilingual (Spanish, Portuguese, French) preferred.
  • Must have excellent written and verbal communication skills and strong presentation and analytical skills.
  • Must have strong interpersonal skills and the ability to demonstrate leadership.
  • Experience working in a global organization, across multiple countries, is required.
  • The ability to provide Therapeutic Area, compound and protocol training within the region and lead local Investigator meetings is required.
  • The ability to influence clinical research strategies to ensure successful execution of current and future clinical trials is required.
  • The ability to collaborate with all levels of management and influence decision-making across a heavily matrixed organization is required.
  • This position will require up to 20% domestic and international travel.

Primary Location
United States-Pennsylvania-Spring House
Other Locations
North America-Canada, Latin America-Brazil, Latin America-Argentina, North America-United States, Latin America-Mexico
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Trial Administration
Requisition ID
3191170226

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