Senior Director, CDTL

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

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

US026 PA Spring House - 1400 McKean Rd

Job Description:

Is a recognized and distinguished expert within Clinical Development who sets vi

Johnson and Johnson is recruiting for a Compound Development Team Leader (CDTL), to be located in Spring House, PA or Boston, MA.  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/.  

The Compound Development Team Leader (CDTL) may work across disease areas (Rheumatology, Gastroenterology, and Immunodermatology) focused on the early portfolio assets. The CDTL will partner closely with the Portfolio & Asset Management organization as part of the wider CDTL community.  They will lead a cross-functional compound development team to maximize the value of the asset and drives execution of the compound strategy. The CDTL champions the project(s) at all levels of J&J through providing clear communication, creative strategic approaches to development and securing appropriate resources to deliver on the milestones.  

The CDTL leads a cross-functional matrix compound development team to deliver against the asset strategy. Beginning at Lead Optimization entry the CDTL drives the development and execution of the compound strategy, working in close partnership with the Discovery Project Leader. The CDTL becomes the sole project team leader at New Molecular Entity Designation and is accountable for Phase 1-3 trials related to the compound development program.

Responsibilities include but are not limited to: 

·        Lead the development and execution of the compound development strategy across multiple indications and/or for multiple programs, creating a vision for each compound within the TA portfolio, including identifying potential indication to be pursued and sequencing of these indications.

·        Assembles and leads an early CDT with representation from appropriate functional partners, for the creation of a Development Plan that provides a thorough and clear asset strategy, integrating input from all functional areas, identifying key development issues and the strategic approach to each, with associated timelines and budgets, offering clarity on alternative pathways and tradeoffs considered.

o   Creates the target product profile in collaboration with commercial, market access and clinical groups, and adjust this profile as new information and insights are gained

o   Drives decision-making on compound strategy, ensuring relevant research, analysis, and expertise are taken into account. 

o   Leads discussions at the CDT to reach decisions, including making final decisions when full consensus cannot be reached.

o   Challenges functional representatives to ensure that all issues and questions are being addressed, and that functional area input into the strategy is adequate to meet the needs of the compound

o   Manages the complexity of internal/external development activities and proactively identifies issues and risks while leading contingency planning and problem solving at early stages of development.

o   Ensures development and implementation of optimal IP, publication and regulatory strategies to protect and maximize asset value.

o   Collaborates closely with the PML on the asset to plan fit-for-purpose resources (FTEs and budget) to deliver the program and ensure adequate project resource utilization and budget management, providing clarity and