HireDiversity

Spring House, PA, US

Clinical Program Leader Immunology-000009T6

Description

Janssen Research & Development, LLC. is recruiting for a Clinical Program Leader (CPL) - Director preferrably located in Leiden, the Netherlands or Springhouse, PA US.

The position is accountable for the successful execution of local, regional and/or global clinical trials for assigned programs/projects within Immunology. This includes amongst others, adequate planning and resource allocation, meeting deliverables within agreed timelines and budget, with high quality and in accordance with 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, the CROs 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) 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.

Principle responsibilities of the CPL include :

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 RFS in terms of outsourcing needs/vendors; if applicable, lead or support CRO selection; partner with other R&D operations organisations in the preparation and assumptions that make up the Request for service 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 Ops 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 Performance PDM, talent management and training requirements

Acquire and sustain advanced knowledge of the therapeutic area and product and clinical trial setting in the TA

Qualifications


Bachelor's Degree (or equivalent) is required. Advanced degree in a scientific discipline and/or Master Degree is preferred.

Candidate has at least 10 years operations experience in clinical trials within a pharmaceutical company, medical device and/or a CRO.

Expertise in the areas of drug development and strategic planning, specifically management of clinical trial operations is required.

This includes 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 has full understanding of all regulatory and logistical aspects when conducting local, regional and/or global Phase 2/ 3 clinical trials. Candidate operates with limited supervision.

Functional management experience of direct reports excluding matrix structure reporting is preferred.

Experience in the Rheumatology and /or Gastrointestinal disorders is preferred.

Candidate possesses 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.

Primary Location:North America-United States-Pennsylvania-Spring House
Other Locations:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Janssen Research & Development, LLC. (6084)