Director, Clinical Operations

Company Description

Job Description

Role Summary:

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.

Key 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 Qualifications:

• 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 Capabilities:

• 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.

Additional Information

Deciphera is committed to fair and equitable compensation practices. 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.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

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.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.