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.

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

About the role

The Associate Director, Cross Therapeutic Area Clinical Risk Management, works with trial 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 trial/program, this role executes data-driven, risk-based oversight activities to ensure quality execution of clinical trials, compliance with regulatory requirements and internal procedures, and maintains a continued state of inspection readiness.

Responsibilities

• Actively and independently participate in all study activities, contributing to the identification and assessment of key risks in clinical protocols and advising clinical team members on effective mitigation strategies for complex trials, compounds, and programs.
• Lead regular reviews of risk areas in collaboration with Risk Owners to evaluate progress of risk mitigations, risk reduction, and 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, 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 through Quality Working Groups and Governance Fora (trial and/or compound, as assigned). Highlight new potential systemic risks to R&D Quality Clinical Risk Management (CRM) management.
• Develop and ensure consistent interpretation of issues requiring quality investigations.
• Provide guidance for significant quality issues (SQI) per corporate standards and escalate SQI to senior R&D management.
• Collaborate with partners in R&D Quality to advise 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, including developing inspection narratives, identifying and preparing sites of interest, ensuring availability of key documents, and coordinating mock inspections 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 of experience 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.
• Flexibility to respond to changing business needs.
• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures.
• Proficiency in Microsoft Office Applications.
• Experience with fundamentals of clinical trial risk management.
• Experience working to ICH guidelines.
• 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.

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) to analyze/interpret collective data and provide insights for 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

• Retirement plan (pension) and savings plan (401(k)).
• Long-term incentive program.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents).
• 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.
• Volunteer Leave: 32 hours per calendar year.
• Military Spouse Time-Off: 80 hours per calendar year.