Senior Specialist, Clinical Trial Transparency and Disclosure (CTD)

The Senior Specialist in Clinical Trial Transparency and Disclosure at Deciphera involves managing the entire transparency and disclosure process for clinical trials. This includes ensuring compliance with global regulations, leading cross-functional teams, coordinating CTD strategy, and developing necessary documentation. You'll also educate the team on industry trends and optimize quality in deliverables.

To qualify for the Senior Specialist role at Deciphera, candidates must hold a Bachelor's degree in pharmacy, biology, chemistry, medicine, or a related field, with a Master’s degree preferred. Additionally, 3 or more years of experience in the pharmaceutical industry, specifically in clinical trial transparency and disclosure, is essential.

Key responsibilities for the Senior Specialist role at Deciphera include overseeing transparency/disclosure deliverables, ensuring compliance with regulations like EU CTIS and ClinicalTrials.gov, developing work instructions, and leading initiatives for maintaining Company Confidential Information. You will also measure compliance metrics to communicate performance effectively.

Deciphera offers a competitive salary and annual bonus, comprehensive benefits including medical, dental, vision insurance, a 401(k) plan with a company match, generous parental leave, and a strong commitment to personal and professional growth through ongoing development opportunities.

Deciphera is committed to equal employment opportunity and values diversity within its workforce. They encourage candidates to voluntarily provide demographic information while assuring that this information remains confidential and is not used in the hiring process, ensuring nondiscrimination in employment decisions.

In your answer, provide specific examples of your past work related to clinical trial transparency, including any relevant projects. Highlight your adherence to regulations such as EU CTIS and ClinicalTrials.gov, showcasing your understanding of the importance of transparency in clinical research.

Discuss your approach to staying updated with regulations, such as attending training sessions and reviewing recent publications. Detail how you have implemented compliance measures in your previous roles, ensuring processes are followed correctly.

Emphasize the critical nature of protecting sensitive information in clinical trials. Provide examples of how you have previously handled confidential information and the measures you take to keep data secure and compliant with relevant laws.

Mention specific tools you are proficient in, such as Microsoft Office, Smart Sheet, or Veeva Vault, and how you've used these tools effectively to manage projects and improve team collaboration in past roles.

Share examples of how you have led training sessions or created guides to educate your colleagues about industry best practices and trends. Discuss your communication skills and how they help convey complex information clearly.

Provide a specific example of a challenge related to clinical trial disclosure, detailing your problem-solving strategies and the outcome. This illustrates your ability to handle difficulties and manage stress effectively.

Talk about the specific metrics you track and the methods you employ to collect data. Explain how you analyze results and how you communicate this information to stakeholders for transparency and improvement.

Discuss your prioritization techniques, such as assessing urgency and importance. Provide examples of how these techniques have led to successful project completions in previous roles.

Emphasize the significance of clear and open communication in ensuring successful collaboration. Share instances when you’ve navigated team discussions and decisions between different departments effectively.

Share your motivation for joining Deciphera, aligning your values with their mission to improve the lives of cancer patients. Discussing your admiration for their commitment to transparency and innovation can resonate positively with interviewers.