Associate Medical Director, Pediatric Development Team

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House Pennsylvania United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at position will serve as an Associate Director for Clinical Immunology products in development with indications in pediatric Immunology Rheumatology Infectious Disease Dermatology or Gastroenterology. The position will support overall strategy protocol design development and addition the candidate would be expected to have input in regulatory interactions and document writing.

The Associate Director responsibilities will include:

• Provides strategic input to pediatric drug development group
• Provides scientific & clinical leadership to pediatric clinical trial teams.
• Responsible for design execution and reporting of Phase 12 and 3 pediatric clinical trials.
• Responsible for monitoring safety of clinical trials and providing scientific leadership in the area of responsibility.
• Contributes to the development of the Integrated Study Plans (concept sheets project plans protocols CRFs operational and analytic plans) and study summaries IND submissions and technical reports. Provides input to strategic decisions regarding therapeutic indications.
• Collaborates with early and late development clinical teams and Compound Development Teams to align pediatric strategy
• Oversees 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.
• Presents data and scientific information to the organization at all levels.
• Builds credible relationships with opinion leaders and External alliances for partnered products when relevant
• Potential for direct line management responsibility

Qualifications for the Associate Director Clinical Development Immunology include:

• MD or DO isrequired
• Board Certification or Eligibility in Pediatrics or Pediatric subspecialty (Immunology Rheumatology Infectious Disease Dermatology Gastroenterology Pulmonology) is highly desirable
• Experience in pharmaceutical drug development or clinical research (academic or industry setting) is highly desirable
• Ability to work in a matrix environment with cross functional teams is essential
• Strong leadership skills and the ability to influence is necessary
• Approximately 10% annual travel may be required (domestic and international)

Required Skills:

Preferred Skills:

Clinical Research and Regulations Clinical Trials Clinical Trials Operations Collaboration Consulting Data Management and Informatics Drug Discovery Development Industry Analysis Innovation Leadership Market Research Regulatory Affairs Management Research Ethics Scientific Evaluation Scientific Research Stakeholder Management Tactical Planning Technical Credibility