Director, Strategy and Delivery – Real World Late Phase

This is a fully remote position, open to applicants in United States, +54 more locations.

📋 Description

• Take charge of customer engagements from pre-award strategy through to study delivery.

• Manage study strategy, proposal creation, bid defense, and oversee operational and financial aspects of assigned studies, programs, and portfolios.

• Collaborate with Business Development and Medical Strategy to acquire new business and enhance account growth.

• Create delivery solutions for both non-interventional and interventional late-phase research.

• Align customer evidence requirements with study design, data availability, country regulations, operational feasibility, and budget constraints.

• Lead the development of proposals, writing, and preparation for bid defenses, including delivery models, country and site strategy, staffing, assumptions, timelines, budgets, and risk management.

• Mentor team members to effectively present expertise and proposed solutions.

• Cultivate customer relationships and identify additional opportunities for follow-up.

• Ensure a seamless transition from proposal phase to delivery.

• Assess populations, endpoints, follow-up schedules, and data sources in collaboration with Epidemiology, Biostatistics, and Medical teams.

• Evaluate primary data collection, secondary data sources, electronic health records, claims, and registries.

• Supervise feasibility, country and site selection, startup, recruitment, retention, monitoring, data collection, and closeout processes.

• Oversee studies and portfolios to ensure adherence to scope, timeline, quality, and financial commitments.

• Analyze performance trends, address escalations, and lead recovery strategies.

• Conduct portfolio reviews and governance discussions.

• Anticipate demand, allocate staff, and balance workload, skills, continuity, and costs.

• Provide line management duties, including recruitment, onboarding, objective setting, mentoring, performance evaluations, development planning, and succession planning as assigned.

• Cultivate project leaders and cross-functional teams.

• Manage financial oversight, including budget assessments, forecasting, resource utilization, profitability, scope management, and change orders.

• Implement GPP, GCP, and relevant local regulations.

• Coordinate ethics reviews, informed consent processes or waivers, privacy, and data governance requirements.

• Maintain oversight of quality risks, deviations, and corrective and preventive actions.

• Ensure readiness for audits and inspections.

• Utilize delivery metrics, customer feedback, and lessons learned to enhance processes, proposal assumptions, budget models, and execution.

⛳️ Requirements

• Bachelor’s degree in life sciences, nursing, public health, epidemiology, or a related field, or equivalent education and relevant experience.

• An advanced relevant degree is preferred.

• Extensive relevant research experience within a CRO, pharmaceutical, biotechnology, or similar research organization.

• Direct experience in delivering both non-interventional and interventional late-phase studies is required.

• Knowledge of observational and interventional study designs, routine-care research, primary and secondary data collection, and their operational implications.

• Familiarity with Good Pharmacoepidemiology Practices (GPP), Good Clinical Practice (GCP), and applicable global and local regulations.

• Proven experience in leading proposals, bid defenses, and high-level customer discussions.

• Experience in translating evidence objectives into practical, appropriately priced delivery plans.

• Experience in portfolio or multi-study oversight, operational problem-solving, financial forecasting, resource planning, and scope management.

• Background in staff development and leadership of cross-functional teams.

• Direct people-management experience is required where the role includes line-management responsibilities.

• Ability to collaborate effectively with Medical, Epidemiology, Biostatistics, Regulatory, Safety, Data Management, and technology partners.

• Adequate therapeutic-area knowledge to lead credible discussions with customers and identify when specialist input is necessary.

• Strong skills in communication, presentation, negotiation, and decision-making.

• Capacity to manage competing priorities and resolve issues with senior stakeholders.

• Proficiency in essential business and project management tools.

• Fluency in English is required.

• Willingness to travel approximately 25% of the time.

• At least eight years of relevant research experience.

• Minimum of seven years managing studies.

• Proven experience leading RWLP programs across both interventional and non-interventional research.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management team.

• Access to technical and therapeutic area training.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive work culture.

• Reasonable accommodations available for applicants with disabilities.