Johnson & Johnson Careers
Requisition ID: 1905753162W
The Director Risk Management and Central Monitoring (RM-CM), is a member of RM-CM Leadership team (LT) in the Integrated Data Analytics and Reporting (IDAR) organization.
The position will provide global leadership to the oncology heme central monitoring managers in the RM-CM department. This includes consistent implementation of Analytical Risk Based Monitoring (ARBM) processes in clinical trials in the oncology heme therapeutic area, in conformance to all relevant laws, regulations, guidelines, policies and procedures and taking leadership in continuous improvement of internal processes and strategy.
At this level, the position has a great degree of impact on the business results and is accountable for managing other RM-CM staff, championing department strategy and collaborating both internally and externally with a high level of influence and independence.
- Accountable for oversight, management and training to a group of central monitors for all activities included in all phases of trial execution as outlined in the end to end process in accordance with standard operating procedures and health authority regulations.
- Can represent Head RM-CM or department at high level and cross-functional meetings and has significant independent decision-making authority.
- Performs hiring, training, talent management and performance development activities of staff for more than one TA.
- Leads and champions risk management standards strategy as well as improvement of internal systems, tools, and processes.
- Expert in leading process improvement working groups.
- Expert in setting functional tactics/strategy/scientific contribution and influencing TA-level strategy.
- Expert in resource management strategy and providing input into hiring decisions.
- Takes on additional major responsibility with minimal guidance or supervision, operating at an expert level with accountability for the highest levels of quality.
- Effectively represents Janssen in external industry/industry organizations
- Minimum B.S. degree required.
- 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.
- Proven experience in people leadership/management including talent development and performance management.
- Proven experience in process improvement and change management.
- Experience in Oncology and Hematology are preferred
- Preferred: Masters Degree in Life Sciences or Medical Doctor degree. Deep understanding of the Janssen R&D clinical operations model including the roles and responsibilities of the different stakeholders.
- Deep knowledge of ICH-GCP and overall drug development processes in the pharmaceutical/medical device industry or CRO.
- Proven experience in people leadership/management including talent and performance management.
- Proven experience in internal and external stakeholder relationship management.
- Proven experience in process development and process improvement.
- Ability to effectively communicate to all levels internal and external to the organization.
- Proven ability to effectively lead in a matrix environment.
Netherlands-North Brabant-Breda-Graaf Engelbertlaan 75
Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Spain, North America-United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse
Janssen-Cilag Netherlands (8345)
Clinical Trial Administration