The posting
We are seeking an experienced and strategic Associate Director, Clinical Operations to lead the execution of global clinical development programs and support the advancement of innovative therapies. This role is responsible for the planning, oversight, and successful delivery of complex clinical studies and programs, ensuring compliance with regulatory requirements, quality standards, timelines, and budgets.
The ideal candidate is a collaborative leader with clinical operations experience, a strong understanding of global clinical trial regulations, and a proven ability to manage CROs, vendors, and cross-functional stakeholders in a fast-paced biotechnology environment.
Objectives
Clinical Program Leadership
- Lead and oversee the execution of multiple clinical studies within assigned development programs.
- Drive operational strategy and execution to support clinical development plans and overall program objectives.
- Manage complex studies that may involve 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.
Vendor and CRO Oversight
- 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 activities.
- Escalate and resolve operational challenges and vendor performance issues as needed.
- Partner with CROs to develop study management, enrollment, communication, monitoring, and risk management plans.
Financial and Strategic Management
- Develop and manage program budgets and forecasts.
- Collaborate closely with Finance to ensure accurate forecasting, enrollment projections, and spend management.
- Provide regular updates to senior leadership regarding program status, risks, timelines, and financial performance.
- Support operational due diligence activities for new compounds, partnerships, and business development opportunities.
Cross-Functional Collaboration
- Serve as the primary Development Operations representative for assigned programs.
- Partner with Clinical Development, Regulatory Affairs, Medical Writing, Biostatistics, Data Management, and other stakeholders to ensure seamless study execution.
- Participate in audit and inspection readiness activities and support regulatory interactions.
- Contribute to departmental process improvements, strategic initiatives, and operational excellence efforts.
Regulatory and Documentation Support
- Contribute operational expertise to the development and review of key clinical development documents, including:
- Protocols
- Clinical Study Reports (CSRs)
- Investigator Brochures
- INDs and IMPDs
- NDA and MAA submissions
- Enrollment and risk management plans
- Support preparation for regulatory agency meetings and health authority interactions.
Leadership and Mentorship
- Provide guidance, mentorship, and support to Clinical Operations team members and cross-functional colleagues.
- Contribute to department training, development initiatives, and resource planning.
- Foster a culture of accountability, collaboration, quality, and continuous improvement
Requirements
- Bachelor's degree; preferably in a scientific discipline
- Minimum of 8 years of clinical/operations experience within 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
- 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.
- Proven ability to influence stakeholders and lead cross-functional teams in a matrix environment.
Benefits
At Phathom, we prioritize the total well-being of our “Phamily” members. Our commitment is reflected in a competitive employee benefits package designed to support employees and their families’ overall well-being, now and in the future, including:
- Highly competitive medical, dental and vision coverage options with low monthly premiums
- Roth & Traditional 401(k) savings plan with annual employer match
- Long-term incentive equity compensation program
- Employee Stock Purchase Plan (ESPP)
- Comprehensive paid leave programs, including:
- 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 in addition to a year-end winter shutdown period
Other Benefits:
- Annual Fitness & Wellbeing Reimbursement
- Company-provided Life and Accidental Death & 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
The expected annual base salary range for this role is $185,000 - 220,000.
Phathom is an equal opportunity employer that is committed to inclusion and diversity and provides equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics.
Applicants with a disability who require a reasonable accommodation for any part of the application, interview or hiring process can contact us by sending an email to [email protected].
