Head Clinical Risk Management Immunology

Job content

Job Description

Janssen Research & Development, LLC, a member of the Johnson & Johnson family of companies, is recruiting for a Head Clinical Risk Management Immunology.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

This position is responsible for the development and management of oversight strategies and programs that ensures that issues are identified and mitigated early, such that the functions, processes and systems, and results within clinical R&D are compliant to Health Authority, industry and standards and regulations. This leader provides strategic quality consultation to key business partner by developing proactive quality support, real-time issue management, using analytics-based data and leveraging cross-therapeutic area expertise. The position is a key leader in the organization to developing future quality leaders, embedding a quality culture in the organization and transforming our capabilities into industry leading.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

Key Responsibilities

• Drive the success of the long-term strategic plans for the R&D Immunology area through effective collaboration with leaders across R&D functions.
• Provide a comprehensive and proactive assessment of quality/GCP compliance-related risks that may impact the safety of human subjects enrolled in clinical trials and/or our ability to meet strategic business objectives. Work with cross-functional partners to ensure efficient use of resources to mitigate risks proactively and address issues reactively that are considered significant.
• Coordinate the clinical R&D and operations units, including but not limited to proactive risk management, clinical trial issue management, CAPA oversight, and inspection management. Liaise with R&D QA team to ensure audit plans address significant risks and issues.
• Represent a broad R&D Quality perspective in key governance meetings where compounds are discussed.
• Provides strategic leadership managing a team of CRM employees in US and EU to ensure consistent quality oversight of the core business, business continuity, routine process improvement, and driving effective communication.
• A minimum of a Bachelor’s Degree is required. Focus degree in Science or Business is preferred.
  
  

Experience and Skills:

Required

• A minimum of 10 years of related work experience in a medium- to large-scale, Life Sciences organization with strong GCP quality and/or clinical trials experience
• Demonstrated experience engaging executive leaders and establishing customer relationships.
• Strong ability to influence a broad array of global Business partners.
• Proven understanding of worldwide clinical safety compliance regulations and guidelines, along with broad exposure to the array of regulatory and legal requirements within the life science industry.
• People management experience
  
  

Preferred:

• Strong GCP quality and/or clinical trials experience in Immunology
• Ability to create relationships with industry peers and to interact, as appropriate and as needed, with quality professionals in third-party organizations, marketing partners and health authority officials.
  
  

Other:

• Proficient in written and spoken English.
• This position may require up to 25% of domestic and international travel
• Proficiency with MS Office products as Word, Excel, PowerPoint, Outlook, MS Visio, and visual aid software
• This position is located at a Janssen R&D office in Belgium, Netherlands, Switzerland, or in one of the Janssen R&D US offices including Horsham, PA, Spring House, PA, Raritan, NJ, Titusville, NJ.
  
  

The anticipated base pay range for this position is $142,000 to $244,950.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

Primary Location

NA-US-Pennsylvania-Spring House

Other Locations

NA-US-Pennsylvania-Horsham, Europe/Middle East/Africa-Switzerland-Basel-Country-Allschwil, NA-US-New Jersey-Titusville, NA-United States, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, NA-US-New Jersey-Raritan

Organization

Janssen Pharmaceutica N.V. (7555)

Travel

Yes, 25 % of the Time

Job Function

Quality (Generalist)

Job Qualifications

Education: