Johnson & Johnson Careers

HEAD RISK MGT CENTRAL MONITORING

Raritan, New Jersey; Leiden, Netherlands; High Wycombe, United Kingdom; Titusville, Florida; Spring House, Pennsylvania; Beerse, Belgium
Clinical Trial Coordination


Job Description

Requisition ID: 0300190326


POSITION SUMMARY

The Head of Risk Management and Central Monitoring (RM-CM), is a member of the Integrated Data Analytics and Reporting (IDAR) Leadership Team (LT) in the Global Clinical Development Operations (GCDO) organization.

The position will provide global strategic leadership to the RM-CM department with responsibility for ensuring that risk management and central monitoring processes are developed, updated and optimized. This includes consistent implementation of Analytical Risk Based Monitoring (ARBM) processes in a broad range of trials in all therapeutic areas, oversight and development of risk libraries across the trials & programs, implementation of processes to facilitate risk management (i.e. proactive identification and mitigation) in clinical development and appropriate resourcing of the department based on the most current portfolio.

The position is the main contact to both the central and regional pillars of the GCDO organization, Therapeutic Area, R&D Bio-Research Quality and Compliance, as well as external collaboration with respect to ARBM strategy and implementation. This position leads a Leadership Team comprising of various Janssen R&D functions both impacted and supported by ARBM.
The position provides strategic direction to his/her direct leadership team, Systems and Analysis core group and the Central Monitoring staff.

PRINCIPAL RESPONSIBILITIES:

1. Provide leadership and global strategic direction for all activities in the RM-CM department;develop the RM-CM into a mature organization with GCDO.

2. Oversee implementation of ARBM, risk management, central monitoring across the Janssen R&D organization and across the various Therapeutic Areas.

3.  Maintain final responsibility for budget, timelines, and quality activities related to ARBM, ensuring effective quality & compliance is maintained or improved and efficiency is introduced in the overall trial monitoring process.

4. Oversee systems development related to RM-CM ensuring alignment with industry standards; ensuring connection with other stakeholders responsible for other operations systems being implemented, maintaining alignment with those and the RM-CM needs.

5.   Oversee continued development of ARBM processes and ensure these are aligned with the industry thinking and applicable guidelines.

6.   Be an ambassador for ARBM implementation across the pharma industry by collaborating with peers in other J&J business sectors and external trade associations on initiatives that shape and influence compliance policies and standards presenting at relevant industry and other types of meetings and stay abreast of the changing regulatory environment

7.   People management responsibility for all staff within his/her group. Overall responsibility to ensure role training for his/her team is completed and current. Support the development of Human Resources programs which include performance management, talent management and training requirements. Provide an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force.

RESPONSIBILITY FOR OTHERS:
  • Supervise, provide day-to-day guidance and support to functional managers, as well as Systems and Analytical core members on team in order to:
  • Develop functional goals and objectives that are aligned with the function / business support team goals and objectives
  • Provide an environment for professional growth of staff which includes actionable feedback, recognition and rewards
  • Provide coaching and mentoring in support of the staff’s development
  • Ensure continued growth in the broader Janssen R&D organization
 
PRINCIPAL RELATIONSHIPS:
  • Reports to VP, Head of IDAR
  • Contacts inside the company may include: Janssen R&D Operations functions, GCDO regional and other central organizations, Janssen R&D IT
  • Contacts outside the company may include:  External vendors as necessary, other pharma companies’ representatives in e.g. TransCelerate, PhUSE, Health Authority representatives

Qualifications
EDUCATION AND EXPERIENCE REQUIREMENTS:


Required Background:


A minimum of a Bachelor of Science (BSc) degree is required; Masters Degree or equivalent with a focus on operation and risk management is preferred.

A minimum of 10 (ten) years of experience in a medium to large scale matrix pharma or CRO with experience in risk management in clinical development; compliance and/or clinical operations background in a related R&D area is required.

Knowledge of ICH-GCP and overall drug development processes is required.


Related Experience:


Expert knowledge of major national and international (e.g. ICH, FDA, MHRA, European Directive, etc…) regulations and guidelines related to clinical development is required.

Proven skills in process development and risk management including risk identification and mitigation. Experience in developing quality risk management tools / metrics is required.

Proven experience in people leadership/ management including talent development, performance management, and building diverse, effective teams is required.

Extensive experience with audits (investigative sites, systems, vendors) and regulatory inspections is required.


General Skills:


Problem solver, proactive strategic thinker, strong leader and collaborator.

Motivated to present at external venues to further solidify RM-CM in the pharmaceutical development environment.

Highly committed to quality, flexible and persistent.

Strong people management skills, with ability to select, motivate and develop professional colleagues fitting the organization.

Good conflict handling/negotiation skills, ability to independently plan, organize, co-ordinate, manage and execute assigned tasks, excellent communicator, with excellent interpersonal skills and diplomacy.

Proficient in Microsoft Office applications.

Excellent knowledge of English is required.

Able to create win-win situations with internal and external partners.



Primary Location
United States-New Jersey-Raritan-
Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Florida-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Trial Coordination
Requisition ID
0300190326