Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Director, Pediatric Clinical Development - Milvexian , to be located in Raritan, NJ . Remote work options may be considered on a case-by-case basis and if approved by the Company.
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.
The Clinical Leader (CL) is responsible for the development and execution of the pediatric development program for Milvexian. including operational implementation, delivered through effective leadership of a cross-functional Clinical Team (CT). The CL leads the team to deliver trial(s) in a timely and cost-effective manner according to the pediatric investigational plan (PIP), protocol(s) development, execution, preparation, and ownership of clinical study reports and for the preparation and approval of essential documents for regulatory filings. The CL may manage direct reports who are project physicians. Team leadership via matrix interactions also includes individuals from project management, operations, regulatory affairs, data management, medical writing, biostatistics, benefit-risk management, pharmacogenomics, drug discovery, early clinical development, clinical pharmacology, clinical operations, health economics, epidemiology, worldwide medical affairs and other scientific and business-related disciplines. The CL is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area.
- Recruitment, supervision, and development of clinical staff assuring diversity of candidates
- Responsible for pediatric clinical development plans and has ownership for the design of clinical trials and for the content of clinical study reports
- Interprets, reports and prepares results of product research in preparation for world-wide health authorities and submissions
- Responsible for medical monitoring/reporting and safety officer activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment
- Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting
- Acts as medical contact at company for worldwide health authorities concerning clinical/medical issues
- Assists Regulatory Affairs in the development of drug/device regulatory strategies
- May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees
- Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities
- Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
- May support early clinical development and discovery activities involving product potential and development for registration
- Participates on evaluation of new product ideas, implement franchise business strategies, etc.
- Responsible for assessment of medical publications emerging from the Team and its affiliates; Responsible, with appropriate colleagues, for review of Company advertising and promotion
- Ensures the study is executed within a budget for all project related clinical activities
Education and Experience:
An MD (or international equivalent) is required. Board Certification or Eligibility, specialization in pediatrics is highly preferred.
Additional education: Significant academic experience is desirable.
A minimum of 10 years of highly successful managerial/supervisory experience is an asset. A minimum of 10 years Drug Development experience is required as well as a minimum of 7 years pharmaceutical industry experience. Also required is Phase II/III development experience including interactions with co-development partners. Worldwide registration experience strongly preferred as well as experience working or interacting with the FDA and PDCO is very strongly preferred. Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required. Energy and enthusiasm are essential. Experience working in a Matrix environment is required. Up to 15-20% yearly travel is required (International as well as Domestic).
Required Technical Knowledge and Skills:
- Fluent in written and spoken English
- Working knowledge of the use of Microsoft software products including Excel and Word
- Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
- Good organizational skills, able to work collaboratively as part of a team in a matrix environment and independently.
- Ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
- Demonstrated ability to think strategically
The anticipated base pay range for this position is $213,000 to $368,000.
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.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, 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.
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.