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Kura Oncology, Inc.Associate Director/Director, Medical & Regulatory Writing
Kura Oncology seeks an Associate Director or Director for Medical and Regulatory Writing to join a commercial-stage biopharmaceutical company focused on precision medicines for oncology. This…
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About this role
Associate Director/Director, Medical & Regulatory Writing at Kura Oncology, Inc. is a full-time role. Work arrangement: Remote. Location: Not specified. No salary is shown in this listing. It was posted on Oct 2, 2026. This listing is paused and not taking applications at the moment.
Job Description
Kura Oncology seeks an Associate Director or Director for Medical and Regulatory Writing to join a commercial-stage biopharmaceutical company focused on precision medicines for oncology. This position suits an experienced medical writer capable of acting as a subject matter expert across various clinical research documents and regulatory submissions. The organization is dedicated to transforming cancer treatment through targeted therapeutics and innovative science. In this capacity, the professional will operate in a fast-paced setting, collaborating closely with multidisciplinary groups to deliver high-quality documentation on schedule.
The person in this role will oversee external vendors, establish operational process improvements, and manage rigorous documentation timelines. Ideal candidates will demonstrate independence in decision-making, a strong background in drug development, and adherence to regulatory standards such as ICH guidelines. Kura Oncology values integrity, grit, relentless execution, and a patient-focused mindset, making this an opportunity for professionals driven to contribute to impactful cancer research.
Responsibilities
- Serve as the subject matter expert for clinical protocols, protocol amendments, clinical study reports, Investigator Brochures, and briefing books
- Partner with cross-functional groups including clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs
- Oversee external vendors such as contract writers, quality control reviewers, and document formatters
- Develop, improve, and maintain departmental work practice documents, standard operating procedures, and document templates
- Utilize EndNote or RightFind Cite It software for literature citations and reference list generation
Requirements
- Hold a Bachelor's, Master's, or PhD degree in a scientific, medical, clinical, or related discipline
- Accumulate 10 to 12 years of relevant industry experience as a medical writer within a pharmaceutical, biotechnology, or contract research organization environment
- Demonstrate hands-on experience authoring clinical study reports, protocols, protocol amendments, and Investigator's Brochures
- Possess proficiency in Microsoft Word along with working knowledge of Microsoft Excel, Microsoft PowerPoint, and Microsoft Project
- Demonstrate familiarity with electronic document management systems such as Documentum, Core Dossier, or Veeva
Qualifications
- Possess a Master's or PhD degree in a scientific, medical, clinical, or related field
- Bring prior oncology writing experience
- Have experience authoring and managing briefing books
- Demonstrate background in regulatory submissions containing clinical study reports presented to regulatory authorities
- Show familiarity with electronic Common Technical Document-compliant templates and formatting tools like ISI writer, Liquent Smart Desk, or Acumen Stylus
Core Skills
Benefits
- Base salary range of $182,000 to $211,000 for Associate Director and $227,000 to $256,000 for Director level
- Participation in an annual target bonus alongside equity and generous stock options
- Employee Stock Purchase Plan
- Twenty days of paid time off to start and eighteen holidays including summer and winter breaks
- Comprehensive benefits package with a substantial employer match, paid paternity and maternity leave, and retirement contributions including 401K
- In-office catered lunches, home office setup, lifestyle spending stipend, commuter stipend for the Boston office, and regular social activities
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the salary range for this position?
The base salary range for an Associate Director is $182,000 to $211,000, while the Director level ranges from $227,000 to $256,000. Actual pay may vary based on factors such as job-related skills, experience, location, and relevant education.
What is the remote work policy for this role?
The job posting indicates that the employment type is full-time and the remote status is on-site.
What level of education is required to apply?
Applicants must hold a Bachelor's, Master's, or PhD degree in a scientific, medical, clinical, or related discipline, with a Master's or PhD being preferred.
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