Senior Operational Strategy Director

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Operational Strategy Director based in the United States.

We are seeking an experienced Senior Operational Strategy Director to lead strategic planning and operational excellence for complex clinical research programs across global markets. In this senior role, you will shape clinical trial strategies, support business development initiatives, and guide the development of competitive proposals for biotech and pharmaceutical clients. You will collaborate with medical, scientific, feasibility, project management, and commercial teams to develop data-driven approaches that optimize patient recruitment, study timelines, budgets, and operational delivery. You will also contribute to client presentations, bid defense meetings, and strategic consulting engagements, ensuring that proposed solutions align with scientific objectives and clinical development goals. Beyond individual opportunities, you will lead initiatives that promote innovation, strengthen operational capabilities, and improve the organization's competitive position in a rapidly evolving clinical research landscape. This opportunity is ideal for a strategic leader who combines extensive clinical operations expertise, financial acumen, and collaborative leadership to deliver high-quality outcomes in a dynamic, global environment. \n

Accountabilities

Operational strategy development:

Lead the development and refinement of operational strategies for prospective clinical research opportunities, evaluating enrollment feasibility, study timelines, startup requirements, therapeutic experience, competitive positioning, and overall delivery considerations. Proposal development and review:

Collaborate with medical, scientific, operational, business development, and proposal teams to develop compelling, evidence-based proposals that integrate operational feasibility, scientific rationale, clinical development objectives, and realistic execution plans. Feasibility and competitive analysis:

Partner with feasibility specialists to assess country and site selection, competitive trial activity, projected recruitment rates, patient availability, and other factors influencing study success. Bid defense and client engagement:

Represent operational strategy during bid defense meetings, pre-award discussions, capabilities presentations, and client meetings. Communicate strategic recommendations clearly and demonstrate how proposed approaches support client objectives. Clinical trial budgeting:

Develop, evaluate, and refine study budgets in collaboration with relevant functional leaders, ensuring financial assumptions align with the proposed operational strategy, study design, timelines, and resource requirements. Cross-functional coordination:

Work closely with Project Management, Clinical Trial Management, medical, scientific, and commercial teams to align operational approaches before bid defense meetings and facilitate effective transitions following contract awards. Post-award strategic alignment:

Participate in post-award engagement meetings to communicate the rationale behind proposed study strategies, share critical assumptions, and ensure delivery teams understand the operational commitments made during the business development process. Strategic innovation initiatives:

Lead and contribute to projects that advance operational innovation, improve clinical research delivery, strengthen internal capabilities, and differentiate the organization as a scientifically driven partner. Client consulting and solution development:

Provide operational and feasibility expertise to clients seeking guidance on clinical development strategy. Collaborate with medical and scientific specialists to develop innovative solutions tailored to study requirements. Technology-enabled strategy:

Use relevant software, web-based applications, and data platforms to support feasibility assessments, analyze competitive landscapes, strengthen recommendations, and improve the quality of bid defense presentations. Knowledge sharing and mentorship:

Mentor and train operational strategy colleagues and other internal stakeholders in clinical research strategy, feasibility assessment, budgeting, and effective proposal development. Industry representation and thought leadership:

Represent the organization at industry conferences, professional meetings, speaking engagements, and exhibitions. Contribute scientific or industry-related articles to relevant publications and digital platforms. Continuous improvement and quality:

Identify opportunities to improve strategic planning, operational processes, resource utilization, and delivery performance while maintaining high standards of quality, compliance, and timeliness. Requirements

Extensive industry experience:

Approximately 18 years of experience in the Contract Research Organization (CRO), pharmaceutical, or clinical research industry, or equivalent relevant experience and demonstrated competencies. Clinical operational strategy expertise:

Extensive experience developing and evaluating operational strategies for complex clinical trials across all phases of clinical development, particularly within relevant therapeutic areas and with a strong understanding of clinical trial execution. Clinical feasibility and study planning:

Demonstrated expertise in assessing enrollment potential, patient recruitment, country and site selection, study startup timelines, competitive trial environments, and operational delivery risks. Proposal and bid defense experience:

Proven ability to develop, review, and present operational strategies for RFPs, bid defense meetings, and pre-award client engagements, translating complex clinical requirements into persuasive and practical recommendations. Budgeting and financial management:

Strong experience developing, reviewing, and refining clinical trial budgets, evaluating resource requirements, and ensuring financial assumptions are consistent with study design and operational delivery plans. Therapeutic area knowledge:

Substantial experience in clinical development within relevant target therapeutic areas, including operational strategy, feasibility, budget development, and execution across clinical trial phases. Regulatory and quality expertise:

Mastery of ICH Good Clinical Practice (ICH-GCP), applicable regulatory guidance, and relevant standard operating procedures, with a commitment to quality, compliance, and patient-focused clinical research. Analytical and problem-solving skills:

Exceptional analytical reasoning and problem-solving abilities, with the capacity to interpret complex clinical and competitive data, evaluate strategic alternatives, and develop evidence-based recommendations. Leadership and organizational capabilities:

Proven leadership skills, including the ability to mentor colleagues, coordinate multidisciplinary teams, manage competing priorities, and deliver high-quality results under tight deadlines. Communication and presentation:

Excellent written and verbal communication skills, active listening, and strong presentation abilities, including the confidence to engage senior stakeholders and communicate complex operational and scientific concepts clearly. Cross-functional collaboration:

Demonstrated ability to work effectively with medical, scientific, feasibility, business development, proposal, project management, and clinical operations teams in a matrixed organization. Technical proficiency:

Strong computer skills, particularly with Microsoft Word, Excel, and PowerPoint, as well as web-based applications, data platforms, and analytical tools used in clinical research. Strategic and operational adaptability:

Ability to maintain a broad strategic perspective while managing detailed operational considerations, work independently and collaboratively, and proactively improve processes, efficiency, and delivery outcomes. Financial and numerical acumen:

Strong numerical reasoning and financial management capabilities to support budget analysis, operational planning, and commercially sound decision-making. Education:

A postgraduate degree is preferred. Travel availability:

Willingness and ability to travel domestically and internationally, including overnight stays, for client meetings, industry events, and business needs. Work authorization:

Candidates must be legally authorized to work in the United States without employer-sponsored immigration support. Benefits

Competitive annual compensation:

Estimated salary range of

$202,400–$304,800

, depending on experience, qualifications, skills, location, and other relevant business considerations. Annual bonus eligibility:

Opportunity to receive a discretionary annual bonus based on applicable compensation policies and performance considerations. Healthcare coverage:

Health insurance benefits to support employee well-being. Retirement savings:

Access to retirement savings benefits to support long-term financial planning. Life and disability insurance:

Coverage options designed to provide financial protection and additional security. Paid time off:

Paid sick leave and vacation time to support work-life balance and personal well-being. Parental leave:

Benefits designed to support employees and their families during important life transitions. Remote work flexibility:

A remote position based in the United States, with travel required for relevant business activities. Professional impact and development:

Opportunities to influence global clinical research strategy, contribute to scientific innovation, collaborate with multidisciplinary experts, and support the development of future operational leaders. Inclusive workplace:

A commitment to equal employment opportunities and reasonable accommodations for individuals with disabilities throughout the recruitment and employment process. \n

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