The position is the GCDO point of accountability at the DAS level for Global Clinical Development Operations (GCDO). GCDO consistes of Global Clinical Operations, Integrated Data Analytics and Reporting(iDAR), Regulatory Medical Writing,Statistical Programming and Portfolio Delivery. The scope of the position includes R&D trials including early development, late development, and phase 3b registration within the specific DAS. The position is ultimately accountable for the successful GCDO delivery of all clinical programs within the assigned DAS and will drive cross-functional operational strategies within GCDO to execute the Disease Area Strongholds (DAS) portfolio.Successful delivery means within timelines and budget and with good quality. This position ensures common operational issues/challenges are identified across programs within the DAS and across GCDO functions and addressed through operational risk mitigation / appropriate escalation to the TA, including proposals for alternative solutions. This position is accountable for ensuring operational execution for insourced and outsourced programs.
This position ensures there is alignment of DAS goals with GCDO organizational objectives as defined in the GCDO & TA cascades. This position ensures the GCDO functions have a good understanding of the portfolio and priorities to allow the functions a pro-active capability building. This position will be responsible to deal with conflicts in priority setting and related resourcing.
This position has direct interface with the correspondent Research & Development Company (R&DC), Project Management Organization (PMO) , Quantitative Sciences (QS), GCDO COEs (iDAR and Trial Coordination and Site Management - TCSM), RTAEs, Clinical Supply Chain, PDMS, CBO, TA and GCDO Finance, Functional Planning, Procurement, Quality & Compliance and senior management in the management of the portfolio.
This position leads a group of GCDO Program Leaders (GPLs) and GCDO Trial Leaders (GTLs). He/she is accountable for the management and development of staff within his/her scope of responsibility while fostering a diverse work force that works seamlessly in a highly matrixed environment. As applicable, this position is responsible for the coordination of all activities performed by the GPLs under the assigned DAS compounds of responsibility. Supports the development of Human Resources programs which may include Performance and Development Management (PDM), talent management and training requirements.
Provides strategic interaction with R&D Company / Disease Area Leader. Be the Point of Contact to discuss new clinical development programs/trials within the DAS and related Licensing & Acquisition (L&A).
Accountable for cross GCDO deliverables within specific DAS portfolio for both insourced and outsourced programs. Coordinates across GCDO (including TCSM, iDAR, Regulatory Medical Writing and Statistical Porgramming and External Alliances ) functions to ensure DAS strategies and operational implications are clearly understood; determines (new) capabilities required (including new vendors to be identified) and ensures GCDO cross-functional operational plans are in place to deliver against the DAS strategies.
Communicate updates from the R&DC/sponsor clinical team to all functions within GCO, IDS and GOS
Ensure timelines are met and regulations are adhered to within the context of the clinical trial plans for the assigned DAS. Responsibilities also include delivery of trials on budget and with quality data.
Ensure GCDO Program Leads (GPL) are allocated to programs and GCDO Program Leads are providing critical cross functional operational input and thorough evaluation of proposed trials / programs.
Review new programs / trials / activities against rest of portfolio & GCDO business priorities. Develops sourcing strategy with TA partners and confirms sourcing strategy with GCDO Operations Head. Ensures common operational issues/challenges are identified and addressed through operational risk mitigation. Ensure timely feedback on deliverables reporting to R&DC Sponsor and TA Clinical Development and DAS leaders.
Ensures accurate budget estimates and predictable delivery of clinical operations, data & writing activities across the DAS portfolio within the agreed upon budget.
As applicable, ensure availability of GPLs and GTLs and be accountable for their performance in support of the DAS demand.
Ensures there is a strong link to Procurement and Finance. Understands all the vendors being used in the DAS and identifies future needs. Works with TA Procurement Laision, the respective Category Managers and finance on DAS specific vendor needs / strategy. The GCDO DAS leader is part of the budget preparation session and attends budget gap meetings.
Establish strong relations with the Q&C organization to ensure first time right, build pro-active risk management plans and drive risk mitigations where appropriate
Provides clinical development operations expertise in the assigned DAS, including integrated solutions and Real World Evidence. Acquires and sustains advanced knowledge of the disease area and product and clinical trial setting in the DAS and strong collaboration with RTAEs. Where needed ensures DAS training is developed and rolled out.
Attends appropriate governance meetings related to trials in DAS.
Supports OH in preparing GCDO leadership on DC and IC meetings for projects being presented.
People management responsibility for all staff within his/her group. Overall responsibility to ensure role training for his/her team are completed and current. Support the development of Human Resources programs which include performance development, talent management and training requirements.
As senior member of PDO organization sponsors, leads and/or supports PDO wide projects.
Establishes strong interaction with relevant R&D partners and RDO / GCDO partners.
University/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, MBA, MD, PhD) is preferred.
A minimum of 10 years of experience in a leadership function in clinical operations with expert knowledge in at least one GCDO function and demonstrated ability to oversee complete scope of GCDO, with a proven track record of people and project management is required.
Disease Area experience and strong portfolio knowledge is required.
Experience in a scientific discipline, with clinical and/or biologics drug development, strategic planning specifically in the pharmaceutical or biotech industries is preferred. Experience in managing external stakeholders/CROs as well as experience in leading registration programs is preferred.
Sound financial acumen; experience with managing a large budget is required. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Experience in solid tumor specific to lung and prostate preferred.
Trusted, inclusive, leader with demonstrated experience in managing and mentoring cross functional, global teams . Effective leadership skills and proven ability to foster team productivity and cohesiveness.
Ability to provide visionary and strategic leadership. Excellent communication and influencing skills and ability to establish strong and enduring relationships in a global matrix environment as well as the innate flexibility to work in a rapidly growing and changing organization.
In addition, the following competencies are required: collaboration and teaming, integrity and Credo based-actions, results and performance driven, sense of urgency, and managing complexity
United States-New Jersey-Titusville-
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-California-La Jolla
Janssen Research & Development, LLC. (6084)
Clinical Trial Coordination