Director Oncology Clinical Risk Management

仕事内容

Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/

J&J Innovative Medicine is recruiting for a Director Oncology Clinical Risk Management reporting to the Sr. Director Oncology CRM within the Clinical Risk Management (CRM) department.

Position Summary

The Director Oncology Clinical Risk Management oversees the overall risk management of the Late Development Hematology Disease Area Stronghold. They work with the CRM Representatives to ensure the coordination of the identification, assessment, and mitigation of quality risks that could have an impact on trial data integrity, patient rights, safety, or well–being.

Throughout the duration of the program, the Director oversees the execution of data-driven, risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness.

Major Duties & Responsibilities

People Leader Responsibilities

• Establishes goals and objectives for CRM Representatives
• Performs mid-year and end-of-year review for CRM Representatives
• Assists in outlining and evaluating career development goals with CRM Representatives
• Works with team members to establish workstreams to update processes for efficiencies and maintaining inspection readiness
• Coordinates upskilling knowledge workshop series for CRM Representative team development
  
  

Risk Management

Independently, the Director Oncology Clinical Risk Management:

• Ensures CRM representatives are invited to actively participate in pre-study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical/cross functional trial team members on effective mitigation strategies.
• Ensures a consistent quality risk assessment process across the program
• Provides and leads strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies. If assigned, approves IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews
• Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews
• Ensures a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations.
• Communicates and facilitates risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).
• Works with risk owners to develop effective risk mitigation plans to control risks in the trial or compound level IQP
• Highlight new potential systemic risks to RDQ CRM management.
  
  

Issue Consultation, Issue Escalation, and Compliance Assessment

In consultation with the Sr. DIRECTOR, Oncology/Early Development Clinical Risk Management:

• Develops and ensures a consistent interpretation of issues that require quality investigations
• Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.
• Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities
• In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)
  
  

Submission Support

Pre-submission Quality Stage Gate Review (SGR)

• Leads SGR content development & follow-up activities
• Coaches and mentors other team members on SGR for coordination and management of activities
  
  

Inspection Readiness and Support

• Independently leads key inspection processes and inspection tools to maintain an ongoing inspection readiness with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
• Provides front and back room support for Sponsor-Monitor inspections at J&J Sites including post inspection support. Provides inspection support per contractual agreement for third party inspections (vendors, co-development partners and contract research organizations)
• Provides remote support for investigational site inspections including post inspection support.
• Provides mentorship and/or coaching for others on inspection support and readiness
  
  

Consultancy

• Provides independent advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.
  
  

Post-licensing and Acquisition (L&A) / Integration

With the guidance from the CRM L&A Team and Therapeutic Head or Delegate:

• Supports and leads the coordination of the quality integration of the acquiring asset or company/partner and delivers robust documentation within the program/trial integration plans (90-day plan) and execute assigned responsibilities per plan.
• Provides and leads general guidance to stakeholders
• As required, provides, and leads input into Quality Agreements with (Co-)development Partners and executes responsibilities per agreement.
• Supports and facilitates asset divestment
  
  

Other Duties

• Participates in CRM, cross-RDQ JJIM, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member or workstream/project lead).
• Works with limited supervision, independently making decisions for compounds and studies
• Provides training and coaching to peers and new employees, as needed.
  
  

Qualifications:

• BA/BSc or equivalent (Scientific, medical, or related discipline)
• A minimum of 10 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) required
• Proficiency in Microsoft Office Applications
• Proficiency in speaking and writing English
• Excellent interpersonal, oral, and written communication skills
• Proven strong GCP quality and/or clinical trials experience
• Experience collaborating in a cross-functional team environment
• Flexibility to respond to changing business needs
• Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures.
• Demonstrates experience or recognizes potential for people leadership in formal or informal setting as needed
• 2 years of People Management Experience
  
  

Preferred Knowledge, Skills And Abilities

• Strong knowledge of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
• Specific Therapeutic Area experience may be required depending on the position.
• Experience with fundamentals of clinical trial risk management
• Global clinical trial experience
• Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance)
• Experience working to ICH guidelines
• Health Authority Inspection experience (FDA, EMA and other inspectorates)
• Strong Project Planning/Management skills
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)
• Proven ability to analyze & interpret collective data to provide insights to drive decision-making
• Experience in managing escalations and CAPA support/advisement
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)
  
  

Percentage Traveled:

Up to 10% (Primarily domestic travel with some international travel)

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