Associate Director/Director, Medical & Regulatory Writing, Boston

Associate Director/Director, Medical & Regulatory Writing

21 Days Old

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.

Essential Job Functions

Prepares, edits, and finalizes synopses, protocols, protocol amendments, investigator brochures, regulatory documents, and related clinical documents. Module 2 clinical summary experience a plus.
Collaborates with the cross-functional team comprised of regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, etc. to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.
Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.
Works closely with the study team to reach consensus on timelines for deliverables.
Completes documents according to agreed-upon timelines for deliverables and follows up with the study team as needed to meet timeline commitments.
Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
Support the development, improvement and maintenance of regulatory and scientific writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.
May assist in providing oversight of vendors including contract writers, QC reviewers, and document formatters.
Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents.
Maintain current knowledge of industry trends and best practices for regulatory and scientific writing.
Performs other duties as assigned

Job Requirements

Masters or advanced degree in scientific, medical, or clinical discipline (eg, PhD, PharmD, or equivalent) is required. PhD degree is preferred.
Must have a minimum of 7+ years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred.
Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator's Brochures. Experience authoring briefing books and Module 2 clinical summaries (2.5, 2.7.3, 2.7.4) is a plus.
Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory interactions, and relevant regulations, requirements and guidance associated with document preparation and submission.
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 with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools is a plus.
Proficient in MS Office Suite, EndNote, and Adobe Acrobat.
Experience with use of an EDMS such as Documentum, Core Dossier, or Veeva.
Ability to travel up to approximately 10% of the time.

The base range for an Associate Director is $175,183 - $204,532 per year and for a Director it is $215,889 - $241,291. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

Kura's Values that are used for candidate selection and performance assessments:

We work as one for patients
We are goal-focused and deliver with excellence
We are science-driven courageous innovators
We strive to bring out the best in each other and ourselves

The Kura Package

Career advancement/ development opportunities
Competitive comp 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 with a substantial employer match
Paid Paternity/Maternity Leave
In-Office Catered lunches
Home Office Setup
Lifestyle Spending Stipend
Commuter Stipend (Boston Office)
Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML"). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at www.kuraoncology.com and follow us on X and LinkedIn.

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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Location:: Boston

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