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Global Program Leader – Medical Affairs Operations (1 of 2)

J&J Family of Companies

This is a Full-time position in Titusville, NJ posted January 13, 2022.

Janssen Research and Development, L.L.C., a member of Johnson and Johnson’s Family of Companies, is recruiting for a Global Program Leader
– Medical Affairs Operations.

This position can be located in Titusville, NJ; Raritan, NJ; Horsham, PA; or Spring House, PA.

Remote locations within the East Coast of the United States may be considered.At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives.

We focus on treating, curing and preventing some of the most devastating and complex diseases of our time.

And we pursue the most promising science, wherever it might be found.Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension.

Please visit anssenrnd.com for more information.The Global Program Leader (GPL)
– Medical Affairs Operation (MAO) will report to the Global Development Operations Head (GOH), and will be accountable for the successful planning, execution and reporting of assigned local, regional and/or global data generation activities or managed access requests.

This will include adequate resource planning and allocation; meeting deliverables within agreed timelines, budget, and with high quality per company procedures and regulatory requirements; as well as driving issue identification and resolution, contingency planning, and decision-making.The GPL will act as the single point of end-to-end accountability at the portfolio/program level.

For the assigned portfolio/program, this individual will manage relationships with global, regional and local Medical Affairs teams, R&D and other internal trial sponsors, as well as with other enterprise sectors, as applicable.

Coordinate all activities within Global Development (GD) Operations
– MAO functions, Development Management, Operations and Analytics (DMOA) and/or with any external service providers (e.g.

Contract Research Organizations (CROs)).The GPL will lead a team of Global Trial Leaders (GTLs), Trial Managers (TMs) and G-Clinical Trial Assistants (G-CTAs).

Along with line management responsibilities, manage and develop staff within their scope of responsibility to meet enterprise wide leadership standards for current and future employment opportunities while fostering a diverse work force that works seamlessly in a highly matrixed environment.Principal Responsibilities:+ Single point of end-to-end accountability for the assigned portfolio/programs.+ Drive the start-up of assigned portfolio/programs.+ Align on project strategy with the Medical Affairs team, R&D, and other internal trial sponsors, as well as with other enterprise sectors, as applicable.+ Provide operational input in the design and implementation of the protocol including sourcing decision per the clinical operating model; either to be executed by GD or an external service provider, where applicable.

Note for Managed Access: Oversee the development of the Managed Access Operations plan including sourcing approach.+ Discuss Clinical Development Plans or Managed Access Strategies and key operational questions with the GOH, as appropriate.+ Ensure GD or external service provider(s) is provided with the Protocol Design Elements/Protocol and critical operational elements in a timely fashion to allow optimal project preparation where applicable.+ Drive the Request for Service (RFS) process, partnering with Global Clinical Operations (GCO); Integrated Data Analysis and Reporting (IDAR), and other GD functions, as well as, DMOA Centers of Excellence (COEs) such as Quantitative Sciences (QS), Pharmaceutical Development and Manufacturing Sciences (PDMS), and Clinical Forecasting and Analytics (CF&A) in the preparation and assumptions that make up the RFS.

As applicable, compile project proposals via the Central Business Operations.+ Oversee the execution and close out of assigned portfolio/programs.+ Ensure effective budget management for all projects.

Partner with the Functional Planning (FP) group for project related milestones and adequate resources.

Ensure accurate trial budget management and reconciliation of all trials for both Out of Pocket (OOP) costs and Full Time Equivalent (FTE) costs.

Oversee GTLs and TMs in the overall contract management, including review and approval of External Service Provider (ESP) contracts, change orders and ensures services are delivered per contract.+ Monitor resource availability and ensure operational consistency across all activities of the Study Management Teams.+ Promote optimal communication between the GTLs/TMs/G-CTAs and GD functions, internal trial sponsors, Global Medical Safety (GMS), Quality Management and Training (QM&T), Clinical Quality Assurance (CQA) and ESPs.+ Ensure timely status updates on project deliverables are provided to the Medical Affairs Team, R&D and other internal trial sponsors and/or other enterprise sectors, as applicable.+ Identify and proactively manage issues in a timely manner.+ Communicate regularly with the GOH on all issues and risks related to project resources, timelines and budget.

Make recommendations for solutions and align with the GOH on the Action Plan.+ Work with relevant project stakeholders and Study Management Teams to implement solutions/Action Plan.+ Ensure that all project objectives are met according to all applicable regulations, legislations, guidelines and internal Standard Operating Procedures (SOPs)/policies.+ Manage and support training and development needs of direct reports to meet the enterprise wide leadership standards for current and future employment opportunities while valuing a diverse work force.+ Acquire and sustain advanced knowledge of the appropriate Therapeutic Area, product and project setting.+ Establish strong relationships with the GOH and other Global Program Leaders within GD across all regions and Therapeutic Areas.Qualifications+ A minimum of a Bachelor’s or equivalent University degree is required, preferably in a scientific discipline (e.g.

Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

Advanced degree (e.g.

Master’s, MBA, MD, PhD) is preferred.+ A minimum of 10 years of experience in clinical operations within the Pharmaceutical industry or Contract Research Organization (CRO) is required.+ Global clinical operational experience (Phase 1-3B) or clinical project management experience is required.+ Experience in the Pulmonary Hypertension and Rare Disease Therapeutic Areas preferred.+ Experience with Late Development clinical trials preferred.+ Knowledge of the drug development process is required.+ Knowledge of Medical Affairs is preferred.+ Experience managing external stakeholders/vendors is required.+ Experience leading a global R&D registration program is preferred.+ CRO management experience is preferred.+ People management experience is required.+ Must have excellent people leadership skills.+ Experience managing budgets required.+ Must have strong financial acumen.+ Must have strong communication skills.+ Must have strong decision-making, negotiating and conflict resolution skills.+ The ability to collaborate with all levels and influence decision-making in a global, matrix environment is required.+ This position will require up to 20% domestic and international travel.Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.Primary LocationUnited States-New Jersey-Titusville-1125 Trenton Harbourton RoadOther LocationsNorth America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring HouseOrganizationJanssen Research & Development, LLC (6084)Job FunctionR&DRequisition ID2105925565W