Director, Cross TA Clinical Risk Mgmt
$150k/y-$258.75k/y
Johnson & Johnson Innovative Medicine2 days ago
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OnsiteFull-timeDirector
Summary
Johnson & Johnson Innovative Medicine is seeking a Director, Cross TA Clinical Risk Management to join their Quality Assurance and Compliance organization in Raritan, NJ; Titusville, NJ; Horsham, PA; Spring House, PA; or Miami, FL. The role involves overseeing the overall risk management of the Cross TA Delivery Unit for Neuroscience, Cardiopulmonary, and Communicable Disease late development trials.
About the Role
As the Director, Cross TA Clinical Risk Management, you will be responsible for managing a team of CRM representatives, overseeing data-driven, risk-based trial oversight activities, and ensuring compliance with regulatory requirements. You will provide strategic guidance on quality risk assessments, facilitate communication with business partners, and lead key inspection processes to maintain inspection readiness.
About You
Required:
- A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required.
- A minimum of 10 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required.
- Proven strong 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.
- Proficiency in Microsoft Office Applications is required.
Preferred:
- Advanced degree in an applicable field of study or certification is preferred.
- Experience with fundamentals of clinical trial risk management is preferred.
- Experience working to ICH guidelines is preferred.
- 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 preferred.
- Immunology Drug Development experience is preferred.
- Strong Project Planning/Management skills is preferred.
- Experience in managing escalations and CAPA support/advisement is preferred.
- Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related) is preferred.
- Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
Benefits
- Competitive salary with an anticipated base pay range of $150k–$258k.
- Eligible for the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Eligible to participate in the Company’s long-term incentive program.
- Vacation – 120 hours per calendar year.
- Sick time – 40 hours per calendar year.
- 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.
- 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.
Johnson & Johnson Innovative Medicine
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
Horsham, PA