Senior Principal Portfolio Lead

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

6d•Hybrid

About The Position

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, 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 Senior Principal Portfolio Lead, located in Spring House, PA, Titusville or Raritan, NJ. Purpose: The Senior Principal 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. 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 position provides matrix leadership to departmental staff. This position plays a critical role in the growth and development of C&SP (Clinical and Statistical Programming) and contributes to organizational effectiveness, transparency, and communication. And directly contributes to delivery of the J&J IM R&D portfolio through effective leadership and accountability of large or complex clinical development and strategic innovation of programs and projects. In collaboration with senior departmental leadership, the Senior Principal Portfolio Lead influences departmental effectiveness acting as a change agent to shape, drive and implement the departmental strategic vision. This position develops strong and productive working relationships with key stakeholders within IDAR in addition to broader partners, external suppliers and/or industry groups.

Requirements

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). Advanced degrees preferred (e.g., Master, PhD).
8+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
Expert knowledge of data structures and relevant programming languages for data manipulation and reporting including Python.
In-depth knowledge of programming practices (including tools and processes).
In depth knowledge of regulatory guidelines (e.g., ICH-GCP).
Project, risk, and team management and an established track record leading teams to successful outcomes.
Excellent planning and coordination of deliverables.
Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.
Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments.
Excellent written and verbal communications skills (in English)
Demonstrated experience managing the outsourcing or externalization programming activities in the clinical trials setting (e.g. working with CROs, academic institutions) is preferred.
Expert CDISC Standards knowledge.

Nice To Haves

Oncology clinical trial experience is highly preferred.
Innovative thinking to allow for optimal design and execution of programming development strategies.
Development and implementation of a business change/innovative way of working.

Responsibilities

Drives the strategy and planning, execution, and completion of all programming activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency.
Leads and designs programming strategy across assigned portfolio over the life cycle of a program to ensure consistency, efficiency, and quality of programming deliverables.
Proactively evaluates and manages 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 manages issue escalations, adopting appropriate escalation pathways.
Collaborates with cross-functional and external partners on programming related deliverables for co-development programs and defining data integration strategy of the assigned programs/projects.
Ensures training compliance and development of appropriate job skills for assigned personnel.
Contributes 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.
Drives the enhancement of functional, technical and/or scientific capabilities within C&SP and shares best practices.
Leads programming related aspects of regulatory agency inspections and J&J internal audits ensuring real time inspection readiness for all programming deliverables.
Provides input to submission strategy to regulatory agencies and ensures 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.
Serves as departmental resource in areas of process and technical expertise.
Stays current with industry trends and policies related to Programming.
Leads departmental innovation and process improvement projects and as required, may contribute programming expertise to cross functional projects/initiatives.
Provides strategic direction within Delivery Unit initiatives and projects.
Serves as a programming expert and influencer on internal and external (industry) work groups.
Represents Programming function in cross-functional initiatives.
Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards.
Responsible for development and implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program.

Benefits

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.
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 Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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