Associate Director - Clinical Operations

Role Summary

Associate Director - Clinical Operations leads and oversees all aspects of clinical studies, ensuring execution aligns with timelines, budgets, and regulatory guidelines. This role partners with cross-functional teams and vendors to support strategic development and execution of clinical programs, while building and guiding a high-performing, inclusive team.

Responsibilities

• Drive and oversee all aspects of clinical studies from planning to close-out, ensuring adherence to timelines, budgets, and regulatory guidelines (FDA, EMA, GCP, ICH) using a risk-based approach.
• Develop and implement operational plans for clinical studies, managing CROs and vendors to ensure high-quality execution.
• Lead internal clinical trial team meetings, tracking key study metrics (e.g., enrollment, site feasibility, and data collection) to ensure progress and alignment with company goals.
• Partner with cross-functional teams (e.g., Clinical, Regulatory, Supply Chain) to support the strategic development and execution of clinical programs.
• Partner with cross-functional team and CRO to ensure patient recruitment and retention strategies are carried out effectively to facilitate on-time study enrollment.
• Ensure efficient database lock by overseeing monitoring plans and taking part in data review and reconciliation efforts.
• Contribute to the development and review of key regulatory documents (e.g., Protocol, Investigator Brochure, Clinical Study Report, Informed Consent Forms, patient-facing materials, and vendor plans).
• Assist in maintaining a quality-focused clinical infrastructure by developing, revising, and implementing SOPs to ensure operational consistency with GXP standards across trials and programs.
• Engage in the planning of quality assurance activities and coordinate remediation of audit findings.
• Lead vendor selection, contract/budget negotiation, and management (including RFP generation, review of SOWs, and Change Orders), serving as a point of escalation as needed.
• Develop and maintain project budget forecasts, ensuring efficient resource allocation, cost-effective execution, and punctual review of invoices.
• Provide ongoing oversight, maintenance and evaluate completeness of the Trial Master File (TMF) by performing periodic QC reviews to ensure the TMF is always "inspection ready‚Äù.
• Lead, mentor, and develop a high-performing team by fostering collaboration, resolving challenges, and ensuring peak performance. Provide training and guidance to junior staff to support their growth and expertise in clinical operations.
• Set clear objectives, delegate responsibilities, and drive strategic alignment with company priorities.
• Cultivate an inclusive and collaborative culture, empowering team members and reinforcing company values.
• Tackle complex challenges by integrating diverse perspectives into innovative, actionable strategies.
• Make data-driven decisions, providing insightful recommendations to shape project timelines, goals, and resource allocation.
• Build strong relationships with senior management and external partners, influencing key project outcomes and ensuring strategic alignment.
• Partner with internal teams and external partners to ensure seamless execution of clinical studies. Foster strong relationships across departments to align objectives, streamline workflows, and drive strategic decision-making.

Qualifications

• Bachelor‚Äôs degree in a life science, allied health field, or other relevant field (e.g. nursing, medical or laboratory technology).
• At least 9 years of relevant experience.

Skills

• Proven ability to lead teams, manage projects, and solve complex problems.
• Strong communication skills, with the ability to persuade and influence partners in sensitive, high-impact situations.
• High emotional intelligence, with the ability to manage both your own emotions and those of others, fostering a collaborative and positive work environment.
• Skilled in conflict resolution and maintaining relationships in challenging scenarios.
• Experience managing contracts, budgets, resources, and schedules to meet performance and project requirements.
• Strategic thinker with the ability to clarify and structure ambiguous problems.
• Experience in policy development and implementation with potential company-wide effects.
• Ability to build and maintain strong team dynamics, proactively preventing and resolving challenges.