Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Clinical Development & Research - Non-MD

Job Category:
Scientific/Technology

All Job Posting Locations:
Spring House, Pennsylvania, United States of America

Job Description:

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 transparency on changes and potential tradeoffs.

o Mentors and coaches assigned team members to lead sub-teams and other Early Development Programs as required.
• Ensures alignment with Leadership and executes on feedback with regard to Go/No Go decisions, timelines, key studies, resource allocations and budgets, valuations and prioritization.
• Present strategic options and champion phase transition proposals at governance boards
• Focuses on overall asset and pipeline value rather than single project value - can balance role as team leader with commitment to maximizing portfolio value - willing to support Go decisions and appropriately come to No Go decisions
• Plays an active role as a member of the CDTL community to help lead and devise strategies for key strategic initiatives and talent development across the Portfolio.
• Represents the CDT on various cross functional committees.
• Leads cross functional/therapeutic area/company initiatives outside of CDT.
• Participates in portfolio/strategy committees within the DAS/TA.

Capabilities:
• Deep understanding of the unmet need addressed by the asset; scientific/disease areas expertise as well as expertise in current and innovative therapeutic development paradigms
• Ability to integrate all cross functional disciplines into a successful strategy
• Strong problem-solving skills for developing creative solutions and meeting project objectives
• Influence, negotiation and conflict resolution skills, including the ability to influence without clear reporting authority
• Ability to identify and manage all stakeholders, including at the most senior levels in the organization
• Demonstrated ability of strategic thinking and contingency planning
• Deep understanding of requirements for successful commercialization of a new product, including competitive and payer landscape across different geographies and pricing strategies
• Strategic Agility: Understanding big picture for compound and Janssen portfolio, translating scientific and business concepts into short and long-term deliverables, managing ambiguity and making decisions with incomplete data

Qualifications - External
• Advanced Degree (Ph.D., M.D., or Pharm.D.,) is preferred
• At least 10 years of pharmaceutical industry experience is preferred
• Experience in a leadership role as part of a research-driven pharmaceutical company is required
• Experience in cross-functional team leadership, including strategy development and driving tactical delivery of programs is required
• Experience in influence, negotiation and conflict resolution skills, including the ability to influence without reporting authority are required
• Outstanding leadership and communication skills are required
• Experience with drug development in Immunology is preferred (experience in early development in preferred)

Required Skills:

Preferred Skills:
Clinical Evaluations, Clinical Trial Protocols, Consulting, Cross-Functional Collaboration, Design Mindset, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Lateral Leadership, Medicines and Device Development and Regulation, Program Management, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management

The anticipated base pay range for this position is :
$196,000.00 - $342,700.00

Additional Description for Pay Transparency:
The anticipated base pay range for this position is: $196,000 - $338,100

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave - 80 hours in a 52-week rolling period10 days

Volunteer Leave - 32 hours per calendar year

Military Spouse Time-Off - 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits