Director Strategy and Delivery Real World Late Phase

Director Strategy and Delivery Real World Late Phase

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Job Summary

The Director, Strategy & Delivery, Real World Late Phase (RWLP), independently leads customer engagements from pre-award strategy through study delivery. The role combines ownership of study strategy, proposal development and bid defenses with operational and financial oversight of assigned studies, programs and portfolios. The Director partners with Business Development and Medical Strategy to secure new business, support account growth and ensure that proposal commitments translate into achievable delivery plans.

The Director develops practical delivery solutions for non-interventional and interventional late-phase research, including prospective and retrospective observational studies, registries, postmarketing safety and effectiveness studies, pragmatic studies and long-term follow-up. Working with Business Development, Medical, Epidemiology, Biostatistics and other functional leaders, the Director translates evidence needs into feasible study plans, budgets and delivery commitments. The role is accountable for customer satisfaction, study and portfolio performance, and the development of assigned teams.

Strategy and customer engagement

·       Lead strategy for assigned RWLP opportunities, aligning customer evidence needs with study design, data availability, country requirements, operational feasibility and budget.

·       Lead proposal development and writing and bid defense preparation, including delivery models, country and site strategy, staffing, assumptions, timelines, budgets and risk mitigation. Coach team members to present their expertise and proposed solutions clearly.

·       Partner with Business Development and account leaders to develop customer relationships, identify follow-on opportunities and demonstrate RWLP capabilities through credible delivery commitments.

·       Ensure an effective transition from proposal to delivery, with clear ownership of commitments, assumptions, scope, resources and customer expectations.

RWLP study design and delivery

·       Apply working knowledge of interventional and non-interventional study designs, including cohort, case-control and cross-sectional studies; prospective and retrospective registries; chart reviews; pragmatic trials; postmarketing studies; and extension or long-term follow-up programs.

·       Partner with Epidemiology, Biostatistics and Medical to assess whether proposed populations, endpoints, follow-up schedules and data sources can answer the study objectives. Translate scientific recommendations into operational plans without substituting for specialist scientific accountability.

·       Assess delivery options using primary data collection, secondary data sources or a combination of both, including electronic health records, claims and existing registries. Identify data access, completeness, linkage, consent and site-workflow requirements with the relevant specialists.

·       Oversee feasibility, country and site selection, startup, recruitment, retention, monitoring, data collection and closeout. Adapt delivery to routine care and site capabilities while meeting protocol and applicable quality requirements.

·       Ensure monitoring and oversight are proportionate to study design, data risks and applicable requirements. Coordinate safety reporting, vendor oversight and event adjudication where required by the protocol.

·       Oversee assigned studies and portfolios against scope, timeline, quality and financial commitments. Review performance trends, resolve escalations and lead recovery plans with clear owners and deadlines.

Operational leadership and people management

·       Lead portfolio reviews and governance discussions; identify recurring delivery issues, capacity constraints and opportunities to improve execution across studies.

·       Partner with functional and resource leaders to forecast demand, allocate staff and balance workload, skills, continuity and cost across the assigned portfolio.

·       Provide line management for designated employees where assigned, including recruitment, onboarding, objective setting, coaching, performance reviews, development planning and succession planning.

·       Assess employee readiness for assigned responsibilities, identify training needs and oversee project handovers and role transitions. Address performance concerns with HR and the appropriate functional leaders.

·       Develop project leaders and cross-functional teams, clarify accountability and promote consistent delivery practices. Maintain defined decision rights with the ODL and functional leadership under the approved operating model.

Financial performance, quality and compliance

·       Own financial oversight for assigned studies and programs, including budget review, forecasting, resource utilization, profitability, scope management and timely change orders. Resolve variances with project teams and Finance.

·       Apply Good Pharmacoepidemiology Practices (GPP), Good Clinical Practice (GCP) and applicable local requirements according to study classification and activities. Work with Regulatory and Quality to confirm the appropriate framework.

·       Ensure compliance with company procedures, contractual commitments and applicable customer requirements. Coordinate ethics review, informed consent or approved waivers, privacy and data governance requirements with the responsible functions.

·       Maintain oversight of quality risks, deviations and corrective and preventive actions; support audit and inspection readiness and timely resolution of findings.

·       Use delivery metrics, customer feedback and lessons learned to improve RWLP processes, proposal assumptions, budget models and execution.

Qualifications

·       Bachelor’s degree in life sciences, nursing, public health, epidemiology or a related discipline, or equivalent education and related experience. An advanced relevant degree is preferred.

·       Extensive relevant research experience within a CRO, pharmaceutical, biotechnology or comparable research organization, including demonstrated leadership of RWLP programs. Direct experience delivering both non-interventional and interventional late-phase studies is required.

·       Demonstrated understanding of observational and interventional study designs, routine-care research, primary and secondary data collection, and their operational implications.

·       Working knowledge of GPP, GCP and applicable global and local requirements for late-phase and non-interventional research, with the ability to apply the appropriate framework with specialist support.

·       Proven experience leading proposals, bid defenses and senior customer discussions, and translating evidence objectives into feasible, appropriately costed delivery plans.

·       Demonstrated portfolio or multi-study oversight, operational problem-solving, financial forecasting, resource planning and scope management.

·       Experience developing staff and leading cross-functional teams. Direct people-management experience is required where the role includes line-management accountability.

·       Ability to work effectively with Medical, Epidemiology, Biostatistics, Regulatory, Safety, Data Management and technology partners; sufficient therapeutic-area knowledge to lead credible customer discussions and identify when specialist input is needed.

·       Strong communication, presentation, negotiation and decision-making skills; ability to manage competing priorities and resolve issues with senior stakeholders.

·       Proficiency in core business and project-management tools; fluency in English; willingness to travel approximately 25%, consistent with business needs.

Critical Skills

RWLP strategy and delivery; study-design literacy; customer engagement; bid defense leadership; portfolio oversight; people development; resource planning; financial management; risk-based quality oversight; cross-functional decision-making.

US Experience Requirements

At least eight years of relevant research experience, including at least seven years managing studies, with demonstrated experience leading RWLP programs across interventional and non-interventional research.

Disclaimer

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

US Physical Requirements and Work Environment

Physical Requirements: Position requires: ability to occasionally move about inside the office to access filing cabinets, office equipment, etc. and to move between office locations; ability to maintain a stationary position for prolonged periods of time; ability to occasionally manipulate (e.g., lift, carry, move) office items and packages of light to medium weights of 10-35 pounds; ability to constantly operate a computer and other office productivity equipment (e.g., scanner, phone, printer, copier); ability to perceive and assess written materials for prolonged periods of time; and ability to frequently communicate with colleagues on the phone, by email, and in-person. Work Environment: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The noise level in the work environment is low.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.