Director, Clinical Operations
About the Role
The Director, Clinical Operations is responsible for ensuring that clinical stage programs achieve strategic and operational objectives within established timelines, budget, and quality standards. This role provides leadership to the Clinical Operations team, contributes to the development of clinical program strategies, and ensures superior execution, collaboration, and transparency across functions. The Director partners with internal stakeholders and external partners to drive high-quality clinical trial delivery in a fast-paced, small-to-midsize biotech environment.
Responsibilities
- Program Strategy & Leadership (35%)
- Develop and execute clinical program strategies that align with corporate goals.
- Provide leadership to the Clinical Operations team and ensure efficient resource allocation across programs.
- Clinical Trial Oversight (25%)
- Ensure clinical trials are properly defined, planned, and executed according to GCP, ICH, and FDA standards.
- Oversee study timelines, budgets, and quality metrics to achieve operational excellence.
- Regulatory & Documentation Support (15%)
- Assist in authoring key regulatory documents and ensure that clinical program deliverables align with submission requirements and regulatory expectations.
- Vendor & CRO Management (15%)
- Manage and oversee CROs, vendors, and external partners to ensure performance, deliverables, and financial accountability meet expectations.
- Team Development & Collaboration (10%)
- Foster a collaborative culture within Clinical Operations and serve as a leadership role model.
- Promote transparent communication, accountability, and operational discipline across the department.
- Other duties and responsibilities as assigned.
Qualifications
Required
- Bachelor’s or Master’s degree in health science or related field required.
- Minimum of 12 years of clinical research experience, with at least 10 years in clinical trial management and operational leadership roles.
- Comprehensive understanding of clinical development processes, GCP, ICH, and global regulatory requirements.
- Proven ability to lead cross-functional teams and manage external CROs and vendors effectively.
- Exceptional leadership, communication, and organizational skills.
- Strong strategic thinking and problem-solving abilities with a focus on operational excellence.
- Proven success managing global clinical programs in a small-to-midsize biotechnology environment.
- Strong Phase III clinical trial experience and demonstrated global experience.
Preferred
- Experience in oncology or rare disease clinical programs preferred.
- Demonstrated success managing global programs in a small-to-midsize biotech environment.
- Experience with clinical systems such as eTMF, CTMS, and EDC platforms.
- Proficiency in budget management and vendor performance tracking.
- Ability to lead in a dynamic, collaborative, and evolving organization.
Pay
The base salary pay range for this role is $190,000 - $261,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.