Associate Director/Director, Medical & Regulatory Writing - Remote

Overview

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

In Short

• Prepares, edits, and finalizes synopses, protocols, and regulatory documents.
• Collaborates with cross-functional teams to interpret study results.
• Manages the document review process.
• Works closely with study teams to reach consensus on timelines.
• Completes documents according to agreed-upon timelines.
• Adheres to established regulatory standards.
• Supports the development of regulatory and scientific writing documents.
• May assist in providing oversight of vendors.
• Maintains knowledge of industry trends and best practices.
• Performs other duties as assigned.

Requirements

• Masters or advanced degree in scientific, medical, or clinical discipline.
• Minimum of 7+ years of relevant industry experience.
• Experience authoring clinical study reports and protocols.
• Ability to work effectively in a collaborative team environment.
• Solid understanding of drug development and clinical research.
• Ability to manage competing priorities in a fast-paced environment.
• Excellent problem-solving and organizational skills.
• Strong attention to detail.
• Proficient in MS Office, EndNote, and Adobe Acrobat.
• Ability to travel up to approximately 10% of the time.

Benefits

• Career advancement opportunities.
• Competitive compensation package.
• 401K with employer contributions.
• Generous stock options.
• 20 days of PTO to start.
• 18 Holidays including Summer & Winter Break.
• Generous Benefits Package with substantial employer match.
• Paid Paternity/Maternity Leave.
• In-Office Catered lunches.
• Home Office Setup.
• Regular employee social activities.