Clinical Program Leader (CPL) - Director, Immunology Job

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Clinical Program Leader (CPL) - Director, Immunology-1158140730
Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Program Leader (CPL) - Director, Immunology to be located in Spring House, PA or Raritan, NJ.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer
The position is accountable for the successful execution of local, regional and/or global clinical trials for assigned programs/projects overseen by Global Clinical Operations (GCO) within a Therapeutic Area (TA), including adequate planning and resource allocation, deliverables within agreed timelines and budget, with high quality and meeting all the SOP and regulatory requirements.
This position acts as the single point of accountability at the program/project level and has direct interface with the Immunology Research & Development and/or clinical teams, Contract Research Organizations (CRO) or GCO's Trial Coordination and Site Management (TCSM) and other relevant functions in the management of clinical trials. This position is responsible for the coordination of all activities performed by the Global Trial Managers (GTMs) and Global Trial Manager-Clinical Trial Assistants (GTM-CTAs) assigned to her/his program/project of responsibility. This position is also responsible for the line management and development of all GTMs and GTM-CTAs assigned to her/his program/project. Position supports the development of Human Resources programs which may include Performance and Development Management (PDM), talent management and training requirements.
The Clinical Program Leader will be responsible for, but not limited to, the following:
Drive the start-up of assigned programs/projects; establish interaction with the TA/R&DC;/sponsor clinical team; align with the TA/ R&DC;/sponsor clinical team on accurate planning; input to Clinical Development Plans and key Operational TA questions; operational input in design and implementation of the protocol; provide key assumptions to Request for Service (RFS) in terms of outsourcing needs/vendors; if applicable, lead or support CRO selection; partner with other R&D; operations organizations in the preparation and assumptions that make up the RFS and program budgets.
Drive the execution and close-out of assigned programs/projects and be central point of communication regarding progress and deliverables between R&D; Operations groups, Finance, PMO and TA.
Provide key input into resolving issues and issue escalation decision making for assigned programs/projects. Ensure that the operational objectives in projects assigned are met in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies as laid out in the End to End (E2E) process map.
As applicable, manage and develop all GTMs and GTM-CTAs assigned to her/his program/project. Supports the development of Human Resources programs which may include PDM, talent management and training requirements
Acquire and sustain advanced knowledge of the therapeutic area and product and clinical trial setting in the TA.
Bachelor's Degree (or equivalent) is required. Advanced degree in a scientific discipline and/or Master Degree is preferred.
A minimum of 10 or more years of operations experience in clinical trials within a pharmaceutical company, medical device and/or a CRO is required.
Expertise in the areas of drug development and strategic planning, specifically management of clinical trial operations is required.
This includes required skills in the following:
Demonstrated technical expertise to manage and lead complex clinical programs (multiple trials, including global registration trials); Experience in selection, set up and collaborating with external vendors, including CROs; Experience in setting up budget expectations and management; Experience managing global teams in a matrix structure and managing or mentoring team members.
Candidate is required to have full understanding of all regulatory and logistical aspects when conducting local, regional and/or global Phase 2/ 3 clinical trials.
Ability to operate with limited supervision is required.
Functional management experience of direct reports excluding matrix structure reporting is preferred.
Experience in the Rheumatology and /or Gastrointestinal disorders is preferred.
Candidate is required to have excellent leadership skills and proven ability to foster team productivity and cohesiveness. Furthermore, candidate has excellent communication skills and the innate flexibility to work in a rapidly growing/changing organization.
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Primary Location: North America-United States-Pennsylvania-Spring House
Other Locations: North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Trial Coordination
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Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
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Req ID: 1158140730
Date: Thu, 31 07 2014 00:00:00 GMT
Country: US
State: PA
City: Spring House
Postal Code: 19477
Locale: en_US

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