Associate Director, Immunology Risk Management

Key Skills

Data science techniques, Effective communication skills, Google Cloud Platform (GCP), Immunology, Leadership Skill, Management, Tableau, US Healthcare Recruitment

Job Description

The ASSOCIATE DIRECTOR (IMM Risk Management) oversees the overall risk management of a program. 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 ASSOCIATE 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.

Key Responsibilities:

Risk Management

• Ensures CRM representatives are encouraged 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 mentorship to CRM representatives on quality risk assessments, risk entries, and mitigation strategies. If assigned, approves IQP (Integrated Quality Plans) risk supervising information in quality risk repository to facilitate regular progress reviews.
• Independently drives quality risk supervising reviews and mentors others on risk monitoring and mitigation reviews
• Ensures crucial 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 R&D QUALITY CRM management.

Issue Consultation, Issue Escalation, and Compliance Assessment

• 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)

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.

With the guidance from the CRM L&A Team and Therapeutic Area 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 Janssen, 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

Education:

• A minimum of a Bachelors or equivalent University degree is required.

Experience and Skills:

• A minimum of 10 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) required.

Required:

• A minimum 8 years of working experience in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required, 10 years relevant working experience is preferred.
• Proficiency in Microsoft Office Applications
• Excellent interpersonal, oral, and written communication skills
• Strong Good Clinical Practices 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.

Preferred:

• 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)

Other:

• Ability to travel up to 10%, domestic travel with some international travel

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]