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Janssen Research & Development, a member of Johnson & Johnson Family of Companies, is recruiting for Associate Director (Risk Management, Central Monitoring).
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular, metabolic, and retinal diseases.
Position Summary:
The Associate Director has a high degree of impact on Risk Management Central Monitoring (RM-CM) business results, championing department strategy and leading and delivering on RM-CM initiatives. This role is expected to independently take on coordinating Analytical Risk-Based Monitoring (ARBM) activities for one or more therapeutic area(s) and/or compound(s) in conformance with all relevant laws, regulations, guidelines, policies and procedures. This role is accountable for the management and deliverables for a team of Central Monitoring Managers (CMM).
Principal Responsibilities:
- Key member of RM-CM Leadership team with accountability for leading and setting the strategy for risk management standards as well as improvement of internal technology and processes
- Accountable for oversight, management and training of CMMs for all RM-CM activities for all phases of trial execution including set-up, execution and close-out as outlined in the end to end process
- Serves as the RMCM representative for assigned programs by establishing and maintaining liaisons with program teams, internal cross-functional colleagues and external contract research organizations (CRO)
- Performs hiring, training, talent management and performance development activities of staff
- Provides status updates to RM-CM Head and appropriately escalates issues for assigned TA(s)
- Ensures process alignment cross-TA and RM-CM and guides CMMs accordingly
- Effectively represents RM-CM in external industry organizations/professional forums
- Represents the RM-CM department at program and cross-functional level meetings
Key Skills (Leading and Expert):
- Deep knowledge of ICH-GCP and overall drug development processes in the pharmaceutical/medical device industry or CRO
- Desire to grow and develop skills in the area of people leadership/management including talent and performance management
- Advanced proficiency in data analysis, risk identification and management of clinical trial data
- Proven experience in internal and external stakeholder relationship management
- Previous experience in process development/improvement and/or technology enhancement
- Advanced analytical skills to apply various systems and technologies to analyse risk related to trial quality/performance and compliance and report trends
- Developing strategies for risk identification and mitigation
- Strong ability to effectively communicate to all levels internal and external to the organization
- Advanced leadership skills allowing smooth and effective communication, including the ability to manage multiple communication streams and exert influence on ARBM concepts with key stakeholders
Principal Relationships:
- Internal: Head RM-CM, CMMs, CTMs, GTLs, GPLs, GOHs, EBIS, Senior Leadership, R&D study team (e.g., Study Responsible Physician, Study Responsible Scientists), other IDAR colleagues/functional leads (SP&A, DML, RMW), Quality, Medical Affairs, and other cross-sector business partners (ex. JJCO)
- External: Vendor representatives, Cross-Pharma Consortiums, Consultants, Health Authorities
Qualifications:
- B.S. in the following science (or equivalent) related fields: Data Science, Chemical Engineering, Biomedical Engineering, Material Science & Engineering, Polymer Science, Microbiology, Biotechnology, Biological Science, Chemistry, Computer Science & Engineering, and Behavioral Science. Eight or more years of relevant work experience
- Solid knowledge of data analytics, statistical concepts and data science principles
- Applied risk management and/or RBM experience
- Master’s Degree in the following science (or equivalent) related fields: Data Science, Chemical Engineering, Biomedical Engineering, Material Science & Engineering, Polymer Science, Microbiology, Biotechnology, Biological Science, Chemistry, Computer Science & Engineering, and Behavioral Science. Deep understanding of the Janssen R&D clinical operations model preferred
- Proven experience in people leadership/management including talent development and performance management preferred
- Sophisticated analytical/statistical skills preferred