Associate Director, Feasibility

Davita Inc.; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Davita Inc. is seeking an Associate Director for the Feasibility Center of Excellence. This role focuses on leading feasibility efforts across clinical trials, optimizing enrollment strategies, and ensuring operational excellence while placing patients at the core of decision-making. The ideal candidate brings significant experience in clinical operations, data insights, and a collaborative spirit.

Qualifications

• 8+ years in CRO or biopharmaceutical managing multinational clinical studies.
• Strong project management skills with multiple projects.
• Broad experience in clinical research and data analytics.

Responsibilities

• Lead feasibility outputs supporting global operational planning.
• Deliver high-quality feasibility work within timelines.
• Assess protocol do-ability and drive study execution.

Skills

Data analytics

Strategic planning

Interpersonal skills

Problem-solving

Communication

Education

University Degree in Science

Higher degree desirable

Tools

Clinical trial management systems (CTMS)

Job description

Overview

The Associate Director (AD), Feasibility Center of Excellence (CoE) is responsible for leading predictable and competitive delivery of indication, program, study, country, and site feasibility across the Clinical Operations portfolio of clinical trials. He/she/they will partner with key leaders/stakeholders to determine appropriate strategies inclusive of protocol optimization, country and site selection, and enrollment forecasting. He/she/they will provide strategic and operational leadership across the enterprise to contribute to furthering business success while ensuring patients and participants are at the center of decision making.

The AD, Feasibility CoE is an effective matrix leader and is skilled in deriving data-driven and technology-enabled insights, enhancing data analytics, developing operational strategies, incorporating site engagement activities, forming an innovative culture, and educating and coaching colleagues and team members. He/she/they is/are critical to broadening data culture and literacy across the Clinical Development organization to ensure strategic planning and effective delivery of Alnylam's portfolio of studies. He/she/they is/are a key leader within Global Trial Optimization (GTO).

The AD, Feasibility CoE leads and facilitates timely and thorough global (end to end) program/indication, study, country, and site feasibility and is/are the primary contact with study team stakeholders across multiple therapeutic and disease area trials. He/she/they consistently delivers high quality insights and application of feasibility practices. He/she/they uses and develops epidemiology, market research, competitive intelligence, past performance, country and site intelligence, and expertise to effectively develop strategies and drive improved decision making for successful trial enrollment outcomes.

The AD, Feasibility CoE partners closely with Clinical Operations and Global Trial Optimization team members, Clinical Research, Program and Project Management, Epidemiology, CRO partners, Regulatory, and other key Expertise Areas to ensure predictable planning and delivery of study start up milestones. He/she/they provides intelligent operational strategies and key data-driven insights to effectively drive portfolio and program operational strategies, feasible study designs, predictive enrollment, and country and site selection. He/she/they provides data-driven assessments of protocol do-ability, patient voice, site and patient burden, study, country and site enrollment scenarios, country and site selection, and risk mitigation strategies to drive predictable and accelerated study execution of global clinical trials. He/she/they leads and oversees protocol optimization and protocol success in coordination with Portfolio and Program Management, Clinical Research, Epidemiology, Medical Writing, Clinical Operations, and CRO partners. Site relationships and engagement are a key focus of this role.

Summary of Key Responsibilities

• Ensures consistent and quality feasibility outputs (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 EA-aligned projects, from program concept through site selection and routinely to monitor enrollment and rescue studies as needed.
• Partners with CROs and vendors to capitalize on historic study/site performance data, competitor trial performance and industry benchmarks using a variety of analytics and modeling tools to drive baseline study milestones targets/dates (CLOCK).
• Partners with Clinical Operations, Regulatory, and Medical Affairs/local country offices to obtain local insights into country and site selection.
• Provides internal expertise in early planning to ensure proposed timelines and committed milestones are accurate and achievable.
• Drives improved KPI/metrics and intelligence to support process improvement and overall operational/business reporting.
• Provides updates on feasibility insights and process to study and program team stakeholders including escalation of key issues, risks and recommended solutions to address
• Leverages and effectively communicates key feasibility insights to influence and inform protocol development, study timelines, operational plans, country and site selection and help inform recruitment and patient recruitment strategies.
• Brings through key commercial and regulatory strategy plans aligned with the clinical development plan.
• Creates, collates, interrogates data provided from data analytics team, CROs, and other EAs, and actively applies insights resulting in concise recommendations.
• Supports and leads governance meetings where feasibility data and insights are required.
• Maintains continuity connecting and documenting changes from early estimates through baseline (CLOCK) and rebaseline, optimizing operational delivery considering time, cost, quality, and burden.
• Effectively listens to stakeholders to understand problem statements and ascertain data to answer key questions for protocol design and execution.
• Continually improves the overall feasibility strategy and process to be flexible, yet systematic across the pipeline.
• Drives a patient- and site-first mindset throughout the organization to create more successful, inclusive, and optimized clinical trials.

Qualifications

• University Degree in Science or related discipline. A higher degree is desirable.
• Significant (8+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies and program strategy and track record of success in global clinical operations, feasibility, or related disciplines.
• Intermediate to advanced skills to leverage, interpret, explain, represent, and drive unbiased data insights into clinical trials operational planning
• Intermediate to advanced skills to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team
• Broad-based experience in clinical research, data analytics, and data evaluation
• Broad experience of managing multinational clinical trials
• Advanced verbal and written communication skills
• Extensive knowledge of drug development, a thorough understanding of the processes associated with feasibility, clinical study start-up, and business operations
  • Demonstrated knowledge of clinical research processes and regulatory requirements.
  • Demonstrated ability to manage complex projects and cross-functional processes required
  • Demonstrated platform skills; experience presenting to large non-science populations
• Strong strategic planning, analytical operational execution, and problem-solving skills
• Highly developed interpersonal skills, including ability to persuade, negotiate, and moderate conflict
• Experience in mentoring and developing junior team members to enhance their skills and career growth.
• Strong project management skills with the ability to manage multiple projects simultaneously.
• Familiarity with clinical trial management systems (CTMS) and external data sources.
• Ability to travel up to 25%.

Requirements

• Must be self-motivated and able to work independently and successfully.
• Able to prioritize effectively, lead and influence, with good problemsolving and planning abilities to enable teams succeed in study start, execution and completion in a timely fashion. Strong organizational skills and ability to deal with competing priorities.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels, including ability to persuade, negotiate, and moderate conflict.
• Ability to analyze complex data and provide actionable insights to drive decision-making.
• Proven ability to build and maintain strong relationships with key stakeholders, including Clinical Research, Regulatory, Epidemiology, Portfolio and Program Management, Commercial, Medical Affairs, Study Start Up, CROs, Study Management, and other Clinical Operations functions.
• Critical reasoning skills including the identification and resolution of complex problems and team leadership challenges.
• Strong problem-solving skills with the ability to identify and mitigate risks effectively.
• Willingness to travel internationally as required. If UK based, bi-annual trips to US headquarters.
• Ideally a combined mix of large company best practices and small company adaptability and experience.
• Willingness and proven ability to work flexibly stepping outside of immediate role responsibilities and wear 'multiple-hats' where needed.
• Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally.
• Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems.

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