Clinical Leader

Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies is recruiting for a Clinical Leader in Translational and Experimental Medicine, Cardiovascular & Metabolism TA.

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.is part of the Janssen Pharmaceutical Companies.

The Clinical Leader in the Translational & Experimental Medicine Group within the Cardiovascular & Metabolism (CVM) Therapeutic Area (TA). Provide strategic, clinical, and scientific leadership of clinical trials through Phase 0 through Ph2a, including mechanistic studies and medical oversight to clinical pharmacology studies.

Essential functions:

• Provides active medical and scientific contribution to a matrixed cross-functional Compound Development Team and Clinical Team, among others.
• Accountable for the design of the Clinical Development Plan
• Accountable for the development of the Translational Early Development Plan which describes the overall clinical development strategy for early-stage compound(s) in collaboration with CVM Discovery, Biomarkers, Late Development, and other functional partners.
• Leads the Clinical Team responsible for the content, quality, and timely completion of key deliverables including protocols, clinical study reports and submissions to health agencies
• Accountable for the medical oversight, conduct, and analysis of the appropriate first in human (FIH), proof of pharmacology (POP), proof of mechanism (POM), and proof of concept (POC) studies for NME early development programs and mechanistic trials as well as medical oversight for the clinical pharmacology studies supporting all early phases of development for the CVM portfolio.
• Provides strategic leadership on managing/addressing specific project/program-related issues and presenting to and negotiating with the CVM and Janssen leadership teams on development plans or program-related issues.
• Presents and/or responds to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations.
• Provides key input into diligence activities.
• Participates or leads cross-departmental or cross-functional projects with broad Janssen impact.
• Authors abstracts and manuscripts for publication based on clinical trial data.
• Builds credible relationships with opinion leaders and may act as company spokesperson regarding publication of research findings and presentations to relevant health authorities and consultant/advisory meetings.
• Participate on and may lead cross-functional teams for evaluation of new scientific opportunities, disease areas, product ideas, implement franchise business strategies, etc.
• Assess external clinical research proposals involving company products relevant to company's mission
• Reviews medical literature and related new technologies
• May be asked to assess medical publications emerging from the Team and its affiliates
• The clinical leader does not have direct supervision (reports). Will be working in a matrixed environment across functional areas.

 

Principal relationships:

Contacts Inside the Company:

• Compound Development Team members
• Discovery
• Biomarkers
• Late development
• Clinical Pharmacology
• Quantitative Sciences
• Business development, Global Commercial Strategy Organizations, etc

Contacts Outside the Company:

• Key opinion leaders and academic collaborators
• Regulatory agencies
• CROs and Clinical Investigators

Qualifications

• Trained nephrologist is a requirement. Bboard certification preferred
• Detailed and thorough understanding of cardiometabolic disorders and in methodology relevant to clinical research is required.
• Requires at least 2 years of experience in drug development and/ or academic clinical research.
• Fluent in written and spoken English
• Strong interpersonal and presentation skills
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings

 

The anticipated base pay range for this position is $187,000 to $280,000.

The Company maintains highly competitive, performance-based compensation programs.  Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.  The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.  Bonuses are awarded at the Company’s discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.  Additional information can be found through the link below. 

For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Primary Location
United States-New Jersey-Somerville-
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2205999898W

Salary : $0