Senior Specialist, Clinical Trial Transparency and Disclosure (CTD)

Job Description

Deciphera is seeking a Senior Specialist in Clinical Trial Transparency and Disclosure (CTD) to join our expanding Global Medical Writing (GMW) & CTD department. This role involves managing transparency/disclosure processes, ensuring compliance, and leading cross-functional teams in developing disclosures for clinical trial programs.

Responsibilities:

• Oversee end-to-end processes for transparency/disclosure deliverables.
• Ensure compliance with global regulations (EU CTIS, EMA Policy 0070, Health Canada PRCI, ClinicalTrials.gov).
• Coordinate CTD strategy and project manage deliverables.
• Educate company-wide on CTD procedures and industry trends.
• Develop CTD work instructions and user guides.
• Provide oversight of quality and vendor/CRO deliverables.
• Assist in operational support of GMW & CTD.
• Lead cross-functional teams in maintaining Company Confidential Information (CCI) and Protected Personal Data (PPD).
• Measure and communicate internal compliance and performance metrics.

Qualifications

• Bachelor's Degree in pharmacy, biology, chemistry, medicine, or equivalent required; Master's of Science Degree preferred.
• 3+ years of experience in the pharmaceutical industry and clinical trial transparency/disclosure.
• Working knowledge of global laws, regulations, and guidelines related to clinical trial documents and data disclosure.
• Experience with plain language summaries, CCI redaction, PPD anonymization, and registration/results postings on ClinicalTrials.gov and EU CTIS.
• Excellent organizational, communication, time, problem-solving, and project management skills.
• Proficient with Microsoft Office products, Smart Sheet, Please Review, Veeva Vault, and Adobe Suite.

Additional Information

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.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.