Executive Medical Director, Immunology

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

People Leader

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is currently seeking an Executive Medical Director, Gastroenterology Late Development to be located in Spring House, PA.

This position will serve as Executive Medical Director for Clinical Immunology for marketed and investigational products in development, with indications in Gastroenterology. The Executive Medical Director will be responsible for oversight of clinical development programs, including design, execution, and reporting of Phase 2 and 3 clinical trials. He/she will provide the highest-level of scientific expertise through entire clinical trial process including interactions with commercial and all level of management.

Responsibilities for the Executive Medical Director include overall program leadership:

• Designing of Clinical development program (CDP), as well as execution and reporting of trials
• Monitoring safety of clinical trials and providing scientific leadership in the area of responsibility
• Providing scientific & clinical leadership of Phase 2 and 3 clinical trial teams
• Leading the development of the Integrated Study Plans and study summaries, IND submissions, and technical reports
• Providing input to strategic decisions regarding therapeutic indications
• Overseeing the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions
• Authorship of abstracts and manuscripts for publication based on clinical trial data
• Presenting data and scientific information to the organization at all levels
• Building credible relationships with opinion leaders and external alliances for partnered products when relevant
• Line management accountability for promotions, recruitment strategy and team structure
• May evaluate in-licensing opportunities and contribute to early development programs

Qualifications - External

• MD is required
• Board certification in a relevant therapeutic area is desired
• Experience in Gastroenterology clinical development desired.
• A minimum of 5 years of clinical research or clinical trials experience preferably in an industry setting is strongly preferred
• Must have strong planning and communication skills to manage and proactively identify resource issues
• Experience in clinical trial design and medical monitoring is highly desired.
• Prior experience in a leadership role is a must.
• This position may require up to 10% annual travel (domestic and international).

Required Skills:

Preferred Skills:

Clinical Research and Regulations, Clinical Trials, Collaborating, Corporate Governance, Data Management and Informatics, Developing Others, Drug Discovery Development, Global Market, Health Care Regulation, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Market Research, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Strategic Change