Kennedy Bond
Clinical Operations Director/Senior Director
Location: Remote (US-based)
Our client, a cutting-edge biopharmaceutical company, is seeking a Clinical Operations Manager / Director to oversee and execute clinical trials across their portfolio. This is an exciting opportunity to contribute to the development of innovative therapies while working closely with cross-functional teams and global partners.
Role Overview The Clinical Operations Manager / Director will be responsible for planning, managing, and executing clinical trials, ensuring adherence to timelines, budget, and regulatory requirements. This role will work collaboratively with clinical development, regulatory affairs, medical affairs, and external partners to ensure operational excellence and successful trial outcomes.
Key Responsibilities Oversee clinical trial operations from start-up through closeout for Phase I–III studies. Develop and manage trial budgets, timelines, and resource plans, ensuring efficient use of internal and external resources. Select, manage, and oversee CROs, vendors, and study sites to ensure high-quality data collection and patient safety. Collaborate with cross-functional teams (clinical development, regulatory, medical affairs, biostatistics) to align operational strategies with program goals. Implement and monitor risk-based monitoring and quality management plans to ensure compliance with GCP, SOPs, and global regulatory requirements. Provide leadership and mentorship to clinical operations staff, promoting a culture of excellence, accountability, and continuous improvement. Prepare operational reports, status updates, and presentations for senior leadership and external stakeholders.
Qualifications Bachelor’s or advanced degree (BS, MS, RN, PharmD) in life sciences, nursing, or a related field. 8–12+ years of progressive experience in clinical operations within biotech, pharma, or CRO. Proven experience managing global clinical trials and working with multi-site, multi-country studies. Strong knowledge of GCP, ICH guidelines, FDA/EMA regulations, and clinical trial compliance standards. Experience managing vendors, CROs, and site relationships effectively. Excellent organizational, analytical, and communication skills. Ability to work independently and lead cross-functional teams in a fast-paced, results-oriented environment. Experience with eTMF, CTMS, and clinical trial systems is preferred.
Please contact Melissa Mallison / m.mallison@kennedybond.com
Our client, a cutting-edge biopharmaceutical company, is seeking a Clinical Operations Manager / Director to oversee and execute clinical trials across their portfolio. This is an exciting opportunity to contribute to the development of innovative therapies while working closely with cross-functional teams and global partners.
Role Overview The Clinical Operations Manager / Director will be responsible for planning, managing, and executing clinical trials, ensuring adherence to timelines, budget, and regulatory requirements. This role will work collaboratively with clinical development, regulatory affairs, medical affairs, and external partners to ensure operational excellence and successful trial outcomes.
Key Responsibilities Oversee clinical trial operations from start-up through closeout for Phase I–III studies. Develop and manage trial budgets, timelines, and resource plans, ensuring efficient use of internal and external resources. Select, manage, and oversee CROs, vendors, and study sites to ensure high-quality data collection and patient safety. Collaborate with cross-functional teams (clinical development, regulatory, medical affairs, biostatistics) to align operational strategies with program goals. Implement and monitor risk-based monitoring and quality management plans to ensure compliance with GCP, SOPs, and global regulatory requirements. Provide leadership and mentorship to clinical operations staff, promoting a culture of excellence, accountability, and continuous improvement. Prepare operational reports, status updates, and presentations for senior leadership and external stakeholders.
Qualifications Bachelor’s or advanced degree (BS, MS, RN, PharmD) in life sciences, nursing, or a related field. 8–12+ years of progressive experience in clinical operations within biotech, pharma, or CRO. Proven experience managing global clinical trials and working with multi-site, multi-country studies. Strong knowledge of GCP, ICH guidelines, FDA/EMA regulations, and clinical trial compliance standards. Experience managing vendors, CROs, and site relationships effectively. Excellent organizational, analytical, and communication skills. Ability to work independently and lead cross-functional teams in a fast-paced, results-oriented environment. Experience with eTMF, CTMS, and clinical trial systems is preferred.
Please contact Melissa Mallison / m.mallison@kennedybond.com