[Hiring] Associate Director, Medical & Regulatory Writing @Kura Oncology

Role Description

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.

The Associate Director, Medical & Regulatory Writing serves as a subject matter expert in the writing and production of clinical documents such as:

• Clinical protocols
• Protocol amendments
• Clinical study reports
• Investigator’s Brochures
• Briefing books

This role is also accountable for Clinical Trial Transparency & Disclosure (CTD) responsibilities and oversight of vendors carrying out such work. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment.

• Serves as the assigned medical writer and subject matter expert in preparing clinical regulatory documents through all phases of clinical research.
• Executes clinical trials transparency and disclosures (CTD) book of work and provides vendor oversight.
• Collaborates with the cross-functional team to interpret study results and ensure accurate reflection in relevant documents.
• Manages the document review process ensuring conflicting comments are clarified and addressed.
• Works closely with the study team to reach consensus on timelines for deliverables.
• Completes documents according to agreed-upon timelines and follows up as needed.
• Adheres to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Supports the development and maintenance of regulatory and scientific writing work practice documents.
• Represents medical writing in cross-functional team meetings.
• Collaborates with department heads and staff members to deliver documents with high quality on time.
• Leads the development of overall global clinical trials transparency and disclosures policy.
• Ensures lean writing practices for regulatory documents to minimize CCI and PPD.
• Analyzes, validates, and prioritizes complex information in response to challenges.
• Manages, tracks, and presents assigned book-of-work, compiling performance metrics.
• Manages the preparation of plain language synopses and summaries in accordance with regulations.
• Educates and provides company-wide awareness of transparency/disclosure regulations.
• Coordinates efforts of cross-functional teams to produce documents and postings.
• Collaborates with stakeholders to develop and implement diversity action plans.
• Works on multiple projects, coordinating work plans that align with corporate timelines.
• Oversight of vendors in the Clinical trial transparency and disclosure space.
• Must have proficiency in the use of Veeva or equivalent IT software for document creation.
• Maintains current knowledge of industry trends and best practices for medical writing.
• Performs other duties as assigned.

Qualifications

• Masters or advanced degree in scientific, medical, or clinical discipline (e.g., PhD, PharmD, or equivalent) is required; PhD preferred.
• Minimum of 8-10 years of relevant industry experience as a regulatory/scientific writer.
• CTD experience; vendor oversight a plus.
• Oncology experience preferred.
• Experience authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochures.
• Ability to work effectively in a collaborative team environment.
• Solid understanding of drug development, clinical research, and relevant regulations.
• Ability to manage competing priorities in a fast-paced environment.
• Excellent problem-solving, organizational, and analytical critical thinking skills.
• Excellent written and verbal communication skills.
• Strong attention to detail related to consistency, grammar, syntax, and formatting.
• Familiarity with eCTD-compliant templates and document formatting tools is a plus.
• Proficient in MS Office Suite, EndNote, and Adobe Acrobat.
• Experience with EDMS such as Documentum, Core Dossier, or Veeva.
• Ability to travel up to approximately 10% of the time.

Requirements

• Makes decisions for assigned programs or functional areas, balancing priorities.
• Facilitates cross-functional coordination for assigned programs or initiatives.

Benefits

• Career advancement/development opportunities.
• Competitive compensation package.
• Bonus.
• 401K + Employer contributions.
• Generous stock options.
• ESPP Plan.
• 20 days of PTO to start.
• 18 Holidays (Including Summer & Winter Break).
• Generous Benefits Package with a variety of plans available.
• Paid Paternity/Maternity Leave.
• In-Office Catered lunches.
• Home Office Setup.
• Lifestyle Spending Stipend.
• Commuter Stipend (Boston Office).
• Regular employee social activities.