Principal Portfolio Lead Clinical Programming

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 .

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

Job Description:

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 (e.g. 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 (e.g. 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 (e.g. 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 (e.g. 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