Global Feasibility TA Head

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The Global Feasibility TA Head (GFH) has primary accountability for GD TA level clinical trial feasibility delivery. The scope of the position includes R&D trials including early development, late development and phase 3b / IV interventional trials. The position is ultimately accountable for the successful delivery of feasibility activities for all clinical programs within the assigned TA(s) and will drive cross-functional feasibility operational strategies. Successful delivery means within timelines and with good quality that support operational planning / decisions resulting in predictable delivery. This position ensures common operational issues/challenges are identified across programs and across functions and addressed through risk mitigation / appropriate escalation to the PDO and GCO, including proposals for alternative solutions. This position is accountable for ensuring feasibility execution for insourced and outsourced programs. This position has direct interface with TAs, DS, and the GD OH’s, GPLs, and relevant Regional / Area management in GCO. The position leads a team of TA-aligned Global Feasibility Leads (GFL) and is a member of the feasibility functional leadership team. The GFH is accountable for ensuring that their TA-aligned team of GFLs is delivering high quality operational insights and partnering with the key stakeholders to create effective protocols and establish robust operational plans. Principal Responsibilities: • Facilitates and drives development of TA level global feasibility strategies including: insights generation / data compilation / assessment and presentation in collaboration with program level stakeholders across GD and TA teams • Leads the TA-aligned GFL team and is responsible for resourcing and performance management • Provides direct supervision and people management for all GFL staff within his/her group. • Overall responsibility to ensure role training for his/her team are completed and current. • Support the development of Human Resources programs which include performance development, talent management and training requirements • Ensures integration of feasibility inputs (data analytics of historical / current clinical trials, epidemiology, standard of care, local country input, etc.) that support global operational planning for clinical trials • Ensures on-time and high-quality delivery of feasibility work and deliverables within the TA aligned projects under remit, from operational plan to operational lock • Ensures consistent standards are applied for the feasibility process across the portfolio in collaboration with peers on the feasibility functional leadership team and study and program teams • Supports development and delivery of global feasibility functional strategy • Defines and drives the feasibility business processes and leads continuous improvement efforts • Develops a country engagement strategy for insights generation aligned with the clinical development plan and trial program footprint for each stage of the feasibility process in collaboration with PDO and GCO • Ensures overviews of the evolving TA feasibility strategy are communicated to the GCO team to enable awareness of risks and challenges and facilitate GCO management input and alignment with feasibility needs • Leads and facilitates specific study-level feasibility activities as required • May assume GFL responsibilities for specific programs Qualifications • Bachelor’s degree is required • 10+ years’ experience in Clinical Operations OR other RELEVANT experience leading and developing staff / functional group(s) is required • Ability to design and develop functional capabilities through process design and effective staff training approaches is preferred • Experience in line management including performance reviews, work allocation, development planning is preferred • Experience overseeing and leading a regional or global team – prior experience managing staff in remote locations is preferred • Extensive experience in the planning and execution of global sponsored clinical research in the pharmaceutical or CRO environments including detailed knowledge of regulations, study design, feasibility, startup, closeout and the associated supportive vendors and technologies is required • Sound understanding of sponsored clinical research study phases and study design principles is required • Demonstrated success/results in prior scientific/administrative management roles including matrix organization is preferred • Demonstrated ability to manage complex projects and cross-functional processes is required • Understands & has demonstrated ability to manage functional budget and assess study budgets is preferred • Highly developed interpersonal skills including effective verbal and written and communication / presentation skills in English and demonstrated business awareness is required • Critical reasoning skills including the identification and resolution of complex problems and team leadership challenges is preferred • Demonstrated ability in proactive management of operational risks is preferred • Knowledge of Drug development is required • Exceptional strategic planning, observation, analytical operational execution and problemsolving skills • Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict • Willingness to travel regionally/globally up to 25% 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 Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Other Locations Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Belgium-Antwerp-Beerse Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105956260W