Associate Dir. Cross TA Risk Management

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.

About the role

The Associate Director, Cross Therapeutic Area Clinical Risk Management, works with trial teams and/or program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well-being, or rights. Throughout the duration of the trial/program, this role executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

This position is available in Horsham, PA; Raritan, NJ; Spring House, PA; Titusville, NJ; Beerse, Belgium; Basel, Switzerland; High Wycombe, UK; and Madrid, Spain.

Responsibilities

• Actively and independently participate in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies for complex clinical trials, compounds, and programs.
• Lead regular review of risk areas in collaboration with Risk Owners to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).
• Maintain Clinical Quality Plans (CQP) in the quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations.
• Independently drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews.
• Communicate and facilitate risk updates to R&D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned). Highlight new potential systemic risks to R&D Quality Clinical Risk Management (CRM) management.
• Develop and ensure a consistent interpretation of issues that require quality investigations.
• Provide guidance for significant quality issues (SQI) per corporate standards and escalate SQI to senior R&D management.
• In collaboration with partners in R&D Quality (RDQ), provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (self-identified, inspection, audit).
• Drive ongoing inspection readiness activities 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 coordinate mock inspections in collaboration with Regulatory Compliance teams.
• Provide support for Investigator, Sponsor-Monitor, and third-party inspections including post-inspection support.
• Provide independent advice on questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.
• Participate in Clinical Risk Management, cross-R&D quality, cross-functional, and cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions.
• Provide training and coaching to peers and new employees, as needed.

Requirements

• A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required.
• A minimum of 8 years working in the healthcare industry (pharmaceutical industry, contract research organization, and/or healthcare/hospital system) is required.
• Proven strong Good Clinical Practice (GCP) Quality and/or clinical trials experience is required.
• Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment is required.
• Flexibility to respond to changing business needs is required.
• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
• Proficiency in Microsoft Office Applications is required.
• Experience with fundamentals of clinical trial risk management is required.
• Experience working to ICH guidelines is required.
• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred.
• Health Authority Inspection experience (FDA, EMA, and other inspectorates) is required.
• Requires proficiency in speaking and writing English.
• Up to 10% travel, primarily domestic with some international travel.

Preferred Skills

• Strong Project Planning/Management skills.
• Experience in managing escalations and CAPA support/advisement.
• Experience and/or proficiency with data analytics and/or data visualization tools (e.g., Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision-making.
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease).

Pay

The anticipated base pay range for this position is $122,000.00 - $212,750.00.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program.

• Time Off Benefits:
  • Vacation – 120 hours per calendar year
  • Sick time – 40 hours per calendar year (48 hours for employees who reside in Colorado; 56 hours for employees who reside in Washington)
  • Holiday pay, including Floating Holidays – 13 days per calendar year
  • Work, Personal, and Family Time – up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • 10 days Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please visit: https://www.careers.jnj.com/employee-benefits.