Deciphera Pharmaceuticals

Customer Success Manager

• Develop a deep understanding of the disease landscapes and contribute to the key customer engagement strategy.
• Manage the day-to-day operations, execution and budget for Peer-to-Peer Programs.
• Partner with marketing operations and medical on the logistics and execution for all congresses.
• Assist in the management of a key customer profile & insights database.

Associate Director, Key Customer Engagement, Sarcoma

Compliance

• Develop regulatory strategies for clinical development programs (which may range from FIH through post-marketing stage).
• Provide solid regulatory solutions and guidance to the cross-functional teams and senior management.
• Provide tactical support and operational expertise with “hands on” support as needed.
• Assess project plans and timelines.
• Work collaboratively to ensure all projects are appropriately prioritized and key goals are met on time.
• Ensure compliance of regulatory strategies and submissions.
• Oversee preparation and review of regulatory submissions and responses.
• Monitor regulatory trends and ensure proactive strategy adjustments.
• Other duties and responsibilities as assigned.

Associate Director, Regulatory Affairs

Medical Director

• Lead clinical strategy and execution for one or more programs; serve as medical monitor and oversee study-level activities.
• Conduct data review in collaboration with clinical science and safety; author clinical and regulatory documents (e.g., protocols, IBs, INDs).
• Engage with KOLs, lead advisory boards and steering committees, and support publications.
• Present findings to leadership and contribute to the scientific and commercial advancement of pipeline assets.
• Partner cross-functionally to drive alignment, communication, and operational excellence across teams as well as between Ono and Deciphera.
• Contribute clinical insights to target assessments, business development, and strategic initiatives.
• Support Medical Affairs and serve as a clinical liaison for study sites and internal teams.
• Participate in continuous improvement efforts and help foster a collaborative company culture.

Medical Director – Clinical Development

Medical writer

• Medical Writing lead for one or more clinical programs, leading the planning, development, and implementation of content strategy for clinical and regulatory documents
• Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in NDA/MAA/IND submission planning and documentation
• Author and manage the preparation of clinical documents and other assigned tasks within established timelines with the highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
• Drive document strategies and messages in a collaborative way with relevant project team subject matter experts
• Maintain cutting edge knowledge base of current developments in field and related technologies. Incorporate process improvements and changes that align with R&D needs
• Excellent written communication skills, detailed-oriented, self-directed and with the ability to be flexible and manage workload of multiple concurrent projects to meet project timelines
• Plan and coordinate work with in-house Medical Writer team and outside CROs
• Mentor junior members of the team, providing guidance and expertise in medical writing
• Strong team player and a change agent who further reinforces/enhances Deciphera’s cultural values
• Experienced and skilled in performing medical literature searches
• Perform reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed

Principal Medical Writer, Global Medical Writing

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

•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