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
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Clinical Development & Research Non-MDJob Category:
Scientific/TechnologyAll Job Posting Locations:
Titusville New Jersey United States of AmericaJob Description:
Job Description:
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 SUMMARY:
The late development Compound Development Team Leader (CDTL) is responsible for development and execution of the compound strategy for a selected molecular entity and operational implementation delivered through the effective leadership of a cross-functional Compound Development Team (CDT). The CDTL is accountable for Phase 2b/3/3b/4 and post marketing clinical trials related to the compound development program and other required cross-functional activities related to lifecycle management. The CDTL leads the team to develop products in a timely and cost effective manner and is accountable for the execution of the compound strategy. Team leadership via matrix interactions includes individuals from TA strategy GCSO global regulatory affairs project management finance legal quality assurance quality monitoring & compliance clinical supplies unit drug discovery early clinical development strategic marketing CM&C preclinical department and other scientific and business related disciplines.
ESSENTIAL FUNCTIONS:
Matrix Leader of Cross-functional Compound Development Team; Works with TA Leadership Team to develop compound strategy
Leads the development and maintenance of the program planand decision-making by providing relevant research analysis and expertise
Manages successful cross-functional execution of the project plan through negotiating with Function heads about functional deliverables
Aligns the CDT to achieve its goals through the networks of people/functions represented on the team
Identifies critical risks and assumptions and transparently communicate them to the CDT functions TA & Pharma governance committees and senior management
Identifies issues and leads contingency planning
Leads resolution of issues at the CDT TA & Pharma governance committees and senior management levels
Leads CDT problem-solving and provide decision-making tools and techniques
Leads the communication of strategy and plans to the TA & Pharma governance committees development partners and other key stakeholders
Responsible for review of medical publications emerging from the Team and its affiliates
Accountable for the budget for the compound or program
Works with Function heads to:
Select CDT members
Set Goals and Objectives for CDT members
Mentor and guide CDT members
Provide input for performance evaluation of CDT members
Execute the program and manage deliverables & financials
May act in concert with senior clinical personnel as a company spokesperson regarding publication of clinical research findings and presentations to relevant health authorities (e.g. global health authority meeting related to NDA/MAA/BLA)
Develop credible relationships with scientific leaders key regulatory officials
Education and Experience:
Advanced Degree (Ph.D. M.D. M.B.A.) highly desirable
A minimum of ten years of pharmaceutical industry or related experience overall and/or a minimum of five to seven years of drug development or related experience
Experience in a leadership role within a multi-functional R&D organization
Ability to integrate all cross functional disciplines into a successful strategy and project plan
Understanding of requirements for successful commercialization of a new product
Expert knowledge of the drug development process and the competitive environment
Strong problem solving skills for developing creative solutions and meeting project objectives
Demonstrated influence negotiation and conflict resolution skills including the ability to influence without clear reporting authority
Significant work experience in a leadership position in a team matrix environment
Strong planning and tracking skills
Demonstrated ability of strategic thinking and contingency planning with respect for Johnson & Johnson Innovative Medicine objectives
Fluent in written and spoken English
Working knowledge of the use of Microsoft suite of software products including Excel and Word
Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
Required Technical Knowledge and Skills:
Fluent in written and spoken English
Working knowledge of the use of Microsoft suite of software products including Excel and Word
Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research Non-MD
Job Category:
Scientific/Technology
Primary Job Posting Location:
Titusville New Jersey United States of America
Additional Job Posting Locations:
Allschwil Switzerland Beerse Antwerp Belgium Cambridge Massachusetts United States of America
Legal Entity Name:
6084-Janssen Research & Development LLC Legal Entity
Pay Grade:
41
Required Skills:
Drug Development Drug Development ResearchPreferred 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 ManagementThe anticipated base pay range for this position is :
$193000 - $333500Additional Description for Pay Transparency:
Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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 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 Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:Exec
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