Deciphera Pharmaceuticals

Clinical Operations

• The Director, Clinical Operations will ensure that clinical stage programs achieve program objectives within established timelines, budget, and quality standards.
• This role involves contributing to the development of clinical program strategy, providing leadership to the clinical operations team, and ensuring superior execution and transparency within the department.
• Key Responsibilities: Develop and execute clinical program strategy
• Lead and manage the clinical operations team for assigned program(s)
• Ensure clinical trials are properly defined, planned, and executed
• Assist in authoring key regulatory documents
• Ensure study objectives align with clinical development strategy and corporate goals
• Manage external vendors to deliver within timelines and budget
• Foster a collaborative culture and serve as a leadership role model
• Qualifications: Bachelor's or Master's degree in health science or related field
• 12+ years of experience, with a minimum of 10 years in clinical trial management
• Expertise in clinical development process, global regulatory requirements, and CRO/vendor management
• Excellent leadership, communication, and organizational skills
• Additional Information: Deciphera is committed to fair and equitable compensation practices and benefits; base salary range is provided.

Director, Clinical Operations

Medical writer

•Lead writer across programs/submissions for clinical study-related documents (protocols, IBs, CSRs)
•Lead cross-functional teams in development of regulatory submission and response documents
•Author and manage preparation of clinical documents with high quality, organization, clarity, accuracy, and adherence to guidelines
•Drive document strategies and messages collaboratively with subject matter experts
•Maintain knowledge of current field developments and incorporate process improvements
•Plan and coordinate work with in-house Medical Writer team and outside CROs
•Mentor junior team members and review deliverables including SAPs, TFLs as needed
•Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and participate in submission planning

Director, Clinical Operations

Principal Medical Writer, Global Medical Writing