Director, Clinical Operations

Waltham, MA - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

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:

Bachelors or Masters 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.

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 $190000 - $261000. 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 Decipheras 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.

Remote Work :

Employment Type :

Full-time

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 ...