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Associate Director, Portfolio Lead Clinical…
- J&J Family of Companies (Titusville, NJ)
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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:
Data Analytics & Computational Sciences
Job Sub** **Function:
Bioinformatics
Job Category:
People Leader
All Job Posting Locations:
Titusville, New Jersey, United States of America
Job Description:
About Innovative Medicine
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.
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
We are searching for the best talent for an Associate Director, Portfolio Lead Clinical Programming within C&SP Group to be located in Titusville, NJ.
**Purpose:** An Associate Director, Portfolio Lead is a highly experienced individual with expert understanding of programming strategies, practices, methods, processes, technologies, industry standards, complex data structures, and analysis and reporting solutions. This position requires strong project and people leadership skills with the capability to effectively coordinate and oversee programming activities across teams in accordance with company and departmental processes and procedures.
As a portfolio leader, this position is responsible for formulating the Programming strategy across a large portfolio of one or more programs within a Disease area and/or Delivery Unit, with accountability for operational oversight and effective planning and execution of programming activities for their assigned portfolio. This position interfaces with program level Delivery Unit Leaders to provide regular status updates, identify and manage risks and issues, and ensures the appropriate use of escalation pathways to appropriate functional leaders as needed.
This role reports into a people manager position within the Delivery unit and is accountable to the Director of Programming for assigned activities and responsibilities such as functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships
Reporting to the Director, Clinical Programming, the Associate Director, Portfolio Lead will:
+ Drive strategy and planning, execution, and completion of all programming activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency.
+ Proactively evaluate and manage resource demand, allocation, utilization, and delivery to meet current and future business needs. Ensure timely and effective maintenance of functional planning systems. May include forecasting related to potential in-licensing and acquisitions.
+ Independently and effectively manage issue escalations, adopting appropriate escalation pathways.
+ Collaborate with cross-functional and external partners on programming related deliverables for co-development programs and defining data integration strategy of the assigned programs/projects.
+ Ensure training compliance and development of appropriate job skills for assigned personnel.
+ Contribute to the development of functional vendor contracts and oversees of delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates. Serves as the primary point of contact for sourcing providers and is responsible for establishing a strategic partnership.
+ Drive the enhancement of functional, technical and/or scientific capabilities within C&SP and share the best practices.
+ Lead programming related aspects of regulatory agency inspections and J&J internal audits ensuring real time inspection readiness for all programming deliverables.
+ Provide input to submission strategy to regulatory agencies and ensure all programming deliverables are complete and compliant.
+ Accountable for actively identifying opportunities, evaluating, and driving solutions to enhance efficiency and knowledge-sharing across programs, value streams and the department.
+ Oversee the design, development, validation, management, and maintenance of clinical databases according to established standards.
+ Responsible for attracting and retaining top talent, proactively managing performance, and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication.
Qualifications / Requirements:
Education:
+ A minimum of a Bachelor's degree (e.g., BS, BA) is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth).
+ An advanced degree (e.g., Master’s, PhD) is preferred.
Experience and Skills:
+ 8+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry is required.
+ Oncology domain knowledge is preferred.
+ Strong project, risk, and team management skills with an established record of leading teams to successful outcomes.
+ Excellent people management skills including staff performance management and people development.
+ Excellent planning and coordinating of deliverables.
+ Proven record collaborating with multi-functional teams in a matrix environment and working with/managing partners, customers, and vendors.
+ Excellent communication, leadership, influencing and decision-making skills.
+ Demonstrated ability to foster team efficiency and cohesiveness adapting to rapidly changing organization and business environments.
+ In-depth knowledge of programming practices (including tools and processes) and regulatory guidelines (e.g., ICH-GCP).
+ Experience managing external programming activities in the clinical trials setting (e.g. working with CROs, academic institutions) is preferred.
+ Solid understanding of CDISC Standards.
+ Strong knowledge of data structures and relevant programming languages for data manipulation and reporting (e.g., SAS, R, Python).
Other:
+ Innovative thinking for optimal design and execution of clinical and statistical development strategies.
The anticipated base pay range for this position is $137,000 to $235,750.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
+ Employees and/or eligible dependents may be 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.
+ Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
+ Employees are eligible for the following time off benefits:
+ Vacation – up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
+ Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
+ Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
This job posting is anticipated to close on 05/06/2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( [email protected] ) or contact AskGS to be directed to your accommodation resource.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
The anticipated base pay range for this position is :
The anticipated base pay range for this position is $137,000 to $235,750.
Additional Description for Pay Transparency:
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