A dynamic and growing Clinical Development team is seeking an Associate Director (AD), Clinical Operations. This individual will be responsible for developing and executing operational strategies, detailed planning, and ensuring robust implementation of global clinical studies in alignment with timelines, budgets, and data quality/compliance goals. The role includes oversight of CRO teams and clinical vendors (e.g., central labs, imaging providers) and close collaboration with multiple internal and outsourced functions, including project management, site monitoring, medical writing, biostatistics, data management, clinical supplies, finance, and document management. Success in this role depends on strong relationships with investigators, CROs, and clinical sites.

Key Responsibilities:

Independently lead and coordinate all aspects of Phase 1-3 clinical study operations, including complex, global studies.
Utilize program management methodologies and performance metrics to monitor progress, assess risk, and implement mitigation strategies through proactive planning and problem-solving.
Collaborate with internal teams and vendors to manage site start-up, including site engagement, recruitment activities, training, and communication.
Develop and implement patient enrollment strategies in partnership with key stakeholders.
Ensure study conduct aligns with timelines, budget, standard operating procedures (SOPs), ICH/GCP guidelines, and all applicable regulations.
Lead cross-functional teams in developing and writing clinical documentation such as protocols, CRFs, informed consent forms, study reports, Investigator's Brochures, and regulatory content.
Act as the primary liaison between clinical vendors and internal stakeholders to ensure alignment on expectations, scope of work, timelines, and budgets.
Provide regular updates on study status, including milestones, budget tracking, and risk assessments, to cross-functional teams and leadership.
Oversee training and compliance with required study systems (e.g., eTMF, EDC, IRT, SharePoint).
Direct or participate in data review and site management to ensure data accuracy and timely entry.
Foster strong, collaborative relationships with internal teams, CROs, vendors, investigators, and study site staff.
Contribute to the development and refinement of SOPs, templates, and work instructions.
May perform line management duties as needed.

Minimum Requirements:

Bachelor's degree in life sciences or equivalent required.
Minimum of 6+ years of experience in clinical study management within a CRO or biopharma environment.
At least 4+ years of experience as a Clinical Trial or Project Manager leading global studies and cross-functional teams.
Minimum 4+ years of experience managing clinical trial vendors (e.g., CROs, central labs).
Preferred experience in managing global Phase 1-3 oncology clinical trials.
Strong familiarity with site start-up activities and related documentation.
Deep understanding of FDA, EMEA, ICH, and GCP regulations and guidelines.
Exceptional organizational and prioritization skills.
Excellent verbal and written communication abilities.
Ability to travel up to 20%.
Proficient in Microsoft Office and project management tools (e.g., Word, Excel, PowerPoint, MS Project, Smartsheet).