Director, Clinical Operations

Deciphera Pharmaceuticals, Inc.; Waltham (MA); Sur place; USD 216 000 - 263 000; Plein temps

Avantages offerts par ce poste

Competitive salary and annual bonus

Comprehensive benefits package

Parental leave

Résumé du poste

Deciphera Pharmaceuticals, Inc. is seeking a Director of Clinical Operations to provide strategic and operational leadership across multiple clinical programs and studies.

The role oversees a small Clinical Operations team and partners across Clinical Development, Regulatory, Data Management, and Safety to ensure timely, high-quality execution. The position requires 12+ years in clinical research with strong program ownership, CRO/vendor management, and deep knowledge of GCP/ICH/FDA.

Qualifications

• 12+ years of clinical research experience with 10+ years in clinical operations leadership.
• Ownership of multiple clinical programs and concurrent trials.
• Experience leading CRO/vendor management with financial accountability.
• Ability to communicate with senior/executive leadership across functions.
• Strong knowledge of GCP, ICH, FDA and global development requirements.

Responsabilités

• Provide Clinical Operations leadership across multiple programs and studies.
• Oversee planning, timelines, budgets, quality, and resource management.
• Lead CRO and vendor relationships with performance and delivery accountability.
• Collaborate with Regulatory, Data Management, Safety, and other teams.
• Communicate program status and risks to senior leadership.
• Contribute to regulatory documentation and submission readiness.

Connaissances

Clinical research

Clinical trial management

Operations leadership

Vendor management

GCP/ICH/FDA knowledge

Cross-functional collaboration

Formation

Bachelor's or Master's degree in health science or related field

Outils

eTMF

EDC

IWRS

RBQM

Description du poste

• Compensation: USD 216,000 - USD 263,000 - yearly

Company Description

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. The spirit of collaboration that has brought medications to life continues to guide how we operate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability - empowering individuals to challenge the unknown together. Learn more about Deciphera, a member of Ono Pharmaceutical Co., Ltd., by visiting our website: https://deciphera.com

Job Description

The Director, Clinical Operations provides strategic and operational leadership across multiple clinical programs and studies, translating clinical development strategy into strong operational execution. This role is responsible for ensuring programs are delivered with quality and accountability across timelines, budgets, and external partnerships.

The Director will initially oversee approximately two clinical programs and lead and develop a small Clinical Operations team. This role is suited for an experienced Clinical Operations leader who has progressed beyond individual study management into broader program ownership while remaining comfortable with hands-on execution in a fast-paced biotech environment.

Key Responsibilities

Clinical Program Strategy & Execution

• Provide Clinical Operations leadership across multiple programs and studies, ensuring alignment with broader development objectives.
• Oversee clinical trial planning and execution, including timelines, budgets, quality, resourcing, operational risks, and key metrics.

Team & Cross-Functional Leadership

• Lead and develop Clinical Operations team members and provide oversight of contractors and external resources.
• Partner across Clinical Development, Regulatory, Data Management, Safety, and other functions to support effective clinical program execution.
• Lead CRO and vendor relationships, ensuring strong performance, financial accountability, quality, and delivery against program expectations.

Program Communication & Regulatory Support

• Communicate program status, risks, and recommendations effectively to senior and executive leadership.
• Contribute to regulatory documentation and ensure clinical deliverables support submission requirements and global regulatory expectations.

Other duties and responsibilities as assigned

Qualifications

• Bachelor's or Master's degree in health science or a related field.
• 12+ years of clinical research experience, including at least 10 years in clinical trial management and Clinical Operations leadership.
• Demonstrated ownership of multiple clinical programs and experience overseeing several clinical trials concurrently.
• Significant experience leading complex clinical trials with accountability for timelines, budgets, quality, and operational delivery.
• Strong CRO and vendor management experience, including performance oversight, financial accountability, risk management, and issue escalation.
• Demonstrated experience leading and developing Clinical Operations team members.
• Ability to communicate effectively with senior and executive leadership and work across functions and geographies.
• Strong knowledge of GCP, ICH, FDA, and global clinical development requirements.

Preferred Capabilities

• Experience supporting global clinical programs, including collaboration with teams and partners in Japan.
• Oncology or rare disease clinical development experience.
• Experience with eTMF, EDC, IWRS, and RBQM platforms.
• Strong clinical program and study budget management experience.
• Experience working within a small-to-midsize biotechnology organization.

Role Specific Additional Information

This role will involve regular collaboration with global colleagues, including teams in Japan, which may occasionally require early-morning or evening meetings. Some travel will also be required for program activities, internal meetings, and industry conferences.

Additional Information

Deciphera believes in providing a fair, equitable, and 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)

• 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.