Associate Director Clinical Operations
About The Position
Phathom is seeking an experienced, strategic Associate Director, Clinical Operations to lead the execution of global clinical development programs and support the advancement of innovative therapies. The role is responsible for planning, oversight, and successful delivery of complex clinical studies and programs in accordance with regulatory requirements, quality standards, timelines, and budgets. The successful candidate will bring clinical operations experience, an understanding of global clinical trial regulations, and the ability to manage CROs, vendors, and cross-functional stakeholders in a fast-paced biotechnology environment. The Associate Director will oversee multiple studies within assigned development programs, drive operational strategy, and manage complex studies that may include multiple indications, interim analyses, DSMBs, endpoint review committees, and global vendors. The role also manages program budgets and forecasts, provides status and risk updates to senior leadership, supports operational due diligence, and represents Development Operations across program teams. The position contributes to clinical documentation and regulatory interactions, supports inspection readiness, and mentors colleagues while advancing operational excellence.
Requirements
- Bachelor's degree; preferably in a scientific discipline.
- At least 8 years of clinical/operations experience in the pharmaceutical, biotechnology, or CRO industry.
- Experience managing complex global clinical trials across multiple therapeutic areas.
- Demonstrated success overseeing CROs, vendors, investigators, and external partners.
- Strong understanding of ICH-GCP, FDA regulations and US CFR requirements, EU Clinical Trial regulations, and global clinical research compliance standards.
- Experience with regulatory inspections and audit readiness activities.
- Excellent project management, organizational, and prioritization skills.
- Strong written, verbal, and presentation communication abilities.
- Ability to influence stakeholders and lead cross-functional teams in a matrix environment.
Responsibilities
- Lead and oversee the execution of multiple clinical studies within assigned development programs.
- Drive operational strategy and execution in support of clinical development plans and program objectives.
- Manage complex studies involving elements such as multiple indications, interim analyses, DSMBs, endpoint review committees, and global vendors.
- Ensure studies are delivered on time, within budget, and in compliance with ICH-GCP, regulatory requirements, and company procedures.
- Oversee project scope, critical path activities, timelines, milestones, and risk mitigation plans.
- Select, manage, and oversee CROs and external vendors to ensure high-quality performance and delivery of contracted services.
- Lead vendor budget discussions, contract negotiations, and performance management; address operational challenges and vendor performance issues.
- Partner with CROs on study management, enrollment, communication, monitoring, and risk management plans.
- Develop and manage program budgets and forecasts, collaborating with Finance on forecasting, enrollment projections, and spend management.
- Provide senior leadership with regular updates on program status, risks, timelines, and financial performance.
- Support operational due diligence for new compounds, partnerships, and business development opportunities.
- Serve as the primary Development Operations representative for assigned programs and partner with cross-functional stakeholders to support study execution.
- Participate in audit and inspection readiness activities and support regulatory interactions.
- Contribute to departmental process improvements, strategic initiatives, and operational excellence efforts.
- Provide operational expertise in developing and reviewing clinical development documents, including protocols, CSRs, investigator brochures, INDs, IMPDs, NDA and MAA submissions, and enrollment and risk management plans.
- Support preparation for regulatory agency meetings and health authority interactions.
- Guide, mentor, and support Clinical Operations team members and cross-functional colleagues.
- Contribute to department training, development initiatives, and resource planning.
- Foster accountability, collaboration, quality, and continuous improvement.
Benefits
- Medical, dental, and vision coverage options with low monthly premiums
- Roth and Traditional 401(k) savings plan with annual employer match
- Long-term incentive equity compensation program
- Employee Stock Purchase Plan (ESPP)
- 16 weeks of paid parental leave for all new parents
- 4-week part-time Bridge-Back-to-Work Program
- Hybrid and flex working arrangements
- Unlimited time off
- 17 paid company holidays and a year-end winter shutdown period
- Annual fitness and wellbeing reimbursement
- Company-provided life and accidental death and dismemberment (AD&D) insurance
- Company-provided short- and long-term disability benefits
- Company-funded HSA plan
- Accident and hospital indemnity insurance
- Employee Assistance Program (EAP)
- Employee recognition program
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
