Associate Director, Clinical Operations in United States Embassy at Jobgether
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Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate Director, Clinical Operations based in United States.
This role offers the opportunity to lead the operational execution of early-phase clinical trials focused on developing innovative therapies for patients with rare diseases.
The position plays a key role in ensuring Phase 1 clinical pharmacology studies are delivered on time, within scope, and according to regulatory standards.
You will collaborate with cross-functional teams, clinical research partners, and external vendors to drive successful study outcomes.
The role combines strategic oversight, operational leadership, and hands-on trial management within a fast-paced biopharmaceutical environment.
You will help shape study strategies, mitigate risks, and ensure operational excellence across complex global programs.
This is an impactful opportunity for a clinical operations leader passionate about advancing meaningful treatments for underserved patient communities.
The Associate Director, Clinical Operations will oversee the planning, execution, and delivery of Phase 1 clinical pharmacology studies while ensuring alignment with timelines, budgets, quality standards, and regulatory requirements. The role requires strong leadership, cross-functional collaboration, and the ability to manage complex clinical programs from start-up through completion.
- 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.
- Provide leadership and guidance to Study Management Teams (SMTs), ensuring delivery of key milestones and adherence to clinical operations plans.
- Review and contribute to clinical study documents, including protocols, informed consent materials, study plans, operational playbooks, and site-facing materials.
- Oversee Phase 1 units, central laboratories, and specialty vendors while ensuring compliance with budgets and forecasts.
- Support continuous improvement of clinical operations processes and best practices.
- Mentor, coach, and develop junior team members while promoting collaboration and accountability.
The ideal candidate will bring extensive clinical trial leadership experience, strong knowledge of Phase 1 clinical pharmacology studies, and the ability to manage complex global programs in a highly regulated environment.
- 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.
- Strong analytical and problem-solving skills with the ability to quickly evaluate challenges and implement solutions.
- Excellent written and verbal communication skills, including experience presenting to senior leadership.
- Ability to adapt to changing priorities while maintaining focus on study objectives and timelines.
- Experience with clinical systems such as IRT, eTMF, and timeline/project management tools such as MS Project or Smartsheet.
- Strong organizational skills with the ability to manage multiple priorities in a dynamic environment.
- Previous people management, coaching, and mentoring experience preferred.
- Ability to travel approximately 10–20% domestically and internationally.
The organization provides a comprehensive rewards package designed to support employee well-being, professional growth, and long-term success.
- Competitive base salary range of $150,000 – $195,000, depending on experience, skills, education, and location.
- Short-term incentive opportunities and long-term incentive compensation through company stock programs.
- Comprehensive healthcare benefits, including medical, dental, and vision coverage.
- Financial wellness benefits, including retirement plans with employer match.
- Life insurance and disability coverage.
- Paid time off and work-life balance programs.
- Wellness initiatives and employee support resources.
- Opportunities for professional development and career growth.
- A collaborative, mission-driven environment focused on advancing treatments for rare disease communities.