Director, Clinical Leader (Established Products)
Johnson & Johnson, is recruiting for a Director, Clinical Leader (Established Products) to be located in the US (Titusville, NJ; Raritan, NJ; or Horsham, PA), Switzerland or Belgium. Other locations in EMEA and APAC may also be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company.
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The EP Clinical Leader reports to the EP Compound Development Team Leader (CDTL) and is accountable for deliverables on assigned products and projects within the portfolio with high scientific quality and within agreed upon timelines and budgets. The Clinical Leader is a critical member of the Compound Development Team (CDT) which is dedicated to maximizing the value of the asset to patients and the company through the execution of all phases of clinical development and provides active medical and scientific contribution to cross-functional clinical teams to support the successful completion of clinical projects and deliverables that enable registrations for new indications, enhancements to the label, and compliance with regulatory commitments for marketed products.
Responsibilities:
- The Clinical Leader acts in concert with senior clinical personnel, as a company spokesperson regarding publication of clinical research findings and presentations to relevant Health Authorities (HAs), such as FDA and EMA, advisory committees, and review meetings.
- Executing clinical studies for new formulations, pediatric exclusivity, post-approval commitments, and new indications. The Clinical Leader leads teams in preparing development plans, protocols, Clinical Study Reports (CSRs), and documents for regulatory ?lings. The Clinical Leader is responsible for medical monitoring and safety reporting of clinical studies.
- Leading Clinical Teams in the ful?llment of Phase IV commitments and other projects as required by HAs.
- Providing active medical and managerial leadership for the operational implementation and execution of clinical programs through matrix management of cross-functional teams. Medical and scientific problems are discussed and solved within teams.
- The Clinical Leader is a core member of the CDTs, a leader of the Clinical Team, and a member of the Global Labeling Teams (GLTs) and Safety Management Teams (SMTs).
- The Clinical Leader acts as a liaison between company and investigators and develops collaborative relationships with key opinion leaders.
- Working with cross-functional teams, such as Regulatory A?airs and Global Medical Safety, to update the Company Core Data Sheets (CCDS), Summary of Product Characteristic (SmPCs), United States Prescribing Information (USPIs), and other local labels for products in the portfolio.
- Collaborating with international teams on responses to requests from HAs and timely implementations of corrective actions as needed.
- Participating in cross-functional teams for evaluation of new product ideas, reviews medical literature, and related new technologies.
