Janssen Pharmaceuticals, Inc, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Scientific Director located in New Jersey / Pennsylvania area
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The successful leader will successfully:
- Develop key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape in CPDP; subsequently continue to liaise with key functional partners to provide product differentiation strategies throughout the drug development continuum.
- Define regulatory strategy for CP and prepare CP contributions to regulatory documents including IBs, IND’s, briefing books, NDA / MAA submissions, bridging documents, post-approval filings, and responses to health authority questions and where appropriate represent CP in relevant external regulatory meetings (eg, End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
- When requested, participate in the evaluation of potential business development opportunities.
- Present and/or publish scientific data at conferences and in peer-reviewed journals, stay abreast of new emerging technologies in relevant scientific fields; identify new opportunities for applied scientific and technical advancement within the division.
- Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
- Apply appropriate regulatory (eg: FDA, EMEA, ICH etc) guidelines in the design of clinical development plans and studies.
- Apply relevant technical trainings/learnings to daily responsibilities, with focus of opportunistic deliver of value/impact. Where appropriate, serves as leader, role model and/or mentor by actively engaging junior members of CP and/or other QS functional colleagues to develop staff professional skills.
- May have people reporting responsibilities.
- Effective and credo-based performance management of scientists supporting projects and in compliance with applicable regulations and company policies
- Promote innovation, creativity, and stimulate colleagues and scientific support staff to pursue new scientific endeavors
- Foster working environment that promotes collaboration, innovation, and creativity
- Participate and/or organize user-group meetings and consortia where applicable
- Train new hires and in-house contractors on CP -related processes
- Assist in process improvement initiatives and SOP development where applicable
- Maintain compliance with Credo standards, Health Care Compliance, and Business Integrity
Minimum Technical Knowledge and Skills:
- Demonstrated understanding of overall process of drug development in pharmaceutical R&D
- Has established a strong level of expertise and scientific reputation through multiple publications and presentations
- Broad drug development experience in one or multiple Therapeutic Areas. Demonstrates understanding of the complexities and recent developments in clinical pharmacology and the implications for drug development. Understands and is able to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies.
- Excellent understanding of model based drug development (MBDD), biopharmaceutics classification system (BCS), and biostatistics principles and tools (eg. gastroplus, simcyp, Winnonlin, NONMEM etc) and demonstrated ability to apply these tools to enable rational and efficient drug development
- Excellent understanding of clinical drug development and the overall pharmaceutical R&D process
- Good understanding of US, European, and Asian regulatory requirements and guidelines
- Good understanding of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s)
Taken necessary training on SOPs to serve as business owner of a GxP regulated application.
- SOP 1705 SDLC (System Development LifeCycle)
- SOP-8602 computer system validation procedure for GxP-regulated applications (previously known as TV-SOP-13574).
- A PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences. A minimum of 10 years experience in the pharmaceutical industry is required.
- A working knowledge of regulatory strategy for CP and prepare CP contributions to regulatory documents including IBs, IND’s, briefing books, NDA / MAA submissions, bridging documents, post-approval filings, and responses to health authority questions and where appropriate represent CP in relevant external regulatory meetings (eg, End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
United States-New Jersey-Raritan-
Janssen Research & Development, LLC (6084)