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 https://www.jnj.com/innovative-medicine
This 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 execution. In 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 1,2 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 is required
- 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
