Associate Director, Clinical Operations
New
J
JobgetherBiopharmaceutical
Based in United StatesFull-TimeDirector
Salary$150,000 – $195,000, depending on experience, skills, education, and location.
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Job Details
- Experience
- 8+ years of progressive clinical trial experience, including at least 2 years in a clinical operations leadership role.
- Required Skills
- Project ManagementGCP
Requirements
- Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline, or equivalent combination of education and relevant experience.
- 8+ years of progressive clinical trial experience, including at least 2 years in a clinical operations leadership role.
- Significant experience managing Phase 1 clinical pharmacology studies and healthy volunteer trials.
- Strong understanding of global clinical research regulations, including US CFR, EU CTD, and ICH E6 (R2) GCP requirements.
- Proven ability to lead cross-functional teams, manage CRO relationships, and drive study execution.
- Experience developing and managing complex clinical project plans, timelines, budgets, and critical paths.
- Experience with clinical systems such as IRT, eTMF, and timeline/project management tools such as MS Project or Smartsheet.
- Previous people management, coaching, and mentoring experience preferred.
- Ability to travel approximately 10–20% domestically and internationally.
Responsibilities
- Lead operational execution of Phase 1 clinical pharmacology studies, including first-in-human, SAD/MAD, DDI, QTc, Human ADME, food effect, and organ impairment studies.
- Manage daily study activities with internal teams, Contract Research Organizations (CROs), clinical sites, and specialized vendors.
- Oversee PK/PD sample collection, processing, reconciliation, and shipment activities.
- Coordinate Safety Review Committee and Dose Escalation Committee meetings when applicable.
- Partner with Clinical Pharmacology, Bioanalytical Sciences, Clinical Supply, Biometrics, and Nonclinical teams to ensure study alignment.
- Identify, assess, and mitigate operational risks associated with early-phase clinical trials.
- Review and contribute to clinical study documents, including protocols, informed consent materials, study plans, operational playbooks, and site-facing materials.
- Support continuous improvement of clinical operations processes and best practices.
- Mentor, coach, and develop junior team members while promoting collaboration and accountability.
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