Job highlights

- Bachelors degree (eg,BS,BA) or equivalent qualified experience 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 (eg,Master,PhD) . .

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:

People Leader

All Job Posting Locations:

Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, India

Principal Portfolio Lead - Clinical Programming - Hyderabad/Bangalore/Mumbai

Position Summary:

The Principal Portfolio Lead - Clinical Programming 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 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 position has at least three direct reports and provides functional area people and/or matrix leadership to departmental staff The role is responsible for the recruitment, onboarding, performance management and development of people and future skills and technical knowledge expertise within their reporting line while building an inclusive and diverse working environment The role plays a critical role in the growth and development of C&SP; and contributes to organizational effectiveness, transparency, and communication

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 role 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

Principal Responsibilities:

As Project Leader:

Drives the strategy and planning, execution, and completion of all programming activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency

Proactively evaluates 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 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

As a People Leader:

Responsible for attracting and retaining top talent, proactively managing performance, and actively supporting talent development and succession planning

Ensures organizational effectiveness, transparency, and communication

Provides mentorship and coaching to programming team members

Ensures training compliance and development of appropriate job skills for assigned personnel

Oversees their work allocation, providing coaching and guidance as necessary

Responsible for local administration and decision making associated with the management of assigned personnel

As a Matrix Leader:

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

Clinical Programming:

Oversees the design, development, validation,



management, and maintenance of clinical databases according to established standards

Principal Relationships:

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

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, and system support organizations

Functional Contacts within J&J; Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources

External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups

Education and Experience Requirements:

Bachelors degree (eg, BS, BA) or equivalent professional experience 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 (eg, Master, PhD)

Experience and Skills Required:

Approx

6+ years of experience (as Principal Programmer) in Pharmaceutical, CRO or Biotech industry or related field or industry

In-depth knowledge of programming practices (including tools and processes)

In depth knowledge of regulatory guidelines (eg, ICH-GCP)

Project, risk, and team management and an established track record leading teams to successful outcomes

Excellent planning and coordinating 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

Demonstrated experience managing the outsourcing or externalization programming activities in the clinical trials setting (eg working with CROs, academic institutions) is preferred

Expert CDISC Standards knowledge

Expert knowledge of data structures and relevant programming languages for data manipulation and reporting

May include SAS, R, Python, etc

Strong people management skills

Other:

Innovative thinking to allow for optimal design and execution of clinical and/or statistical development strategies

Development and implementation of a business change/innovative way of working

Required Skills:

Preferred Skills:

Advanced Analytics, Analytical Reasoning, Biostatistics, Clinical Data Management, Collaboration, Compliance Management, Data Privacy Standards, Developing Others, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Survey Design, Team Management

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Principal Portfolio Lead - Clinical Programming (Mumbai)
🏢 Johnson u0026 Johnson
📍 Mumbai