Job Description
The Associate Director, Clinical Operations is a key leadership role responsible for strategic planning, execution, and oversight of complex early-phase clinical trials and/or programs. This individual is accountable for operational delivery, financial stewardship, quality, compliance, timelines, and budget performance.
This role operates at the program level, influencing cross-functional strategy, advancing operational innovation, and driving excellence across Clinical Operations. The position may include direct people management responsibilities or operate as a senior individual contributor, depending on business needs.
Responsibilities:
- Lead execution of complex early-phase studies and/or multiple studies within a program, from planning through closeout.
- Provide operational oversight to ensure delivery against timelines, budgets, quality standards, and regulatory requirements.
- Drive program-level strategy, including study design input, feasibility, risk mitigation, resource planning, and execution planning.
- Accountable for study and program financial management, including forecasting, budget oversight, and resource allocation.
- Partner with Clinical Development, Clinical Pharmacology, Research, Regulatory, Biometrics, and other functions to align and deliver program objectives.
- Lead CRO/CRU/vendor selection, contract negotiations, and ongoing performance management.
- Influence program and organizational decision-making through operational expertise and data-driven insights.
- Lead or contribute to cross-functional and organizational initiatives, including transformation, change management, and continuous improvement efforts.
- Serve as a subject matter expert or Business Process Owner for Clinical Operations processes, SOPs, tools, and systems.
- Proactively identify study and program risks and implement mitigation strategies.
- Ensure compliance with global regulatory requirements, including FDA, EMA, ICH-GCP, and internal SOPs.
- Demonstrate leadership through influence across internal and external stakeholders.
- _people manager responsibilities apply_ _:_
- Lead, mentor, and develop clinical operations staff, fostering a high-performance and inclusive culture.
- Provide coaching, feedback, and career development planning aligned with organizational goals.
- Empower teams through clear goal-setting, accountability, and removal of operational barriers.
- Oversee inspection readiness and support audit activities as needed.
Basic qualifications:
- Bachelor’s degree (or RN) with 10+ years of relevant clinical research or life sciences experience, OR
- Advanced degree (MS, MA, PharmD, PhD, MBA) with 8+ years of relevant experience.
- Demonstrated experience leading complex clinical trials and/or programs.
- Strong knowledge of global clinical regulations (FDA, EMA), ICH-GCP, and clinical trial processes.
Preferred qualifications:
- Experience in early-phase clinical development.
- Proven ability to lead cross-functional teams and influence without authority.
- Experience with CRO/vendor sourcing and oversight.
- Strong strategic thinking and ability to connect operational execution with broader business objectives.
- Demonstrated experience with process improvement, innovation, or operational transformation initiatives.
- Excellent communication, collaboration, and stakeholder management skills.
- Ability to manage complexity, prioritize competing demands, and deliver results in a fast-paced environment.
- When needed, ability to travel.
People Leader Accountabilities:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
