Assoc Dir/Director, Regulatory Affairs Boston, Massachutsetts

Kura Oncology, Inc; Boston (MA); On-site; USD 172,000 - 250,000; Full time

Job summary

Kura Oncology, a leading biopharmaceutical company, is looking for an Associate Director/Director of Regulatory Affairs. This role involves developing and implementing regulatory strategies, managing IND/CTA submissions, and ensuring compliance with regulations. Ideal candidates will possess extensive regulatory experience, strong leadership skills, and a commitment to patient-focused outcomes.

Benefits

Competitive compensation package

Bonus

401K with employer contributions

Generous stock options

ESPP Plan

20 days of PTO to start

18 Holidays including Summer & Winter Break

Paid Paternity/Maternity Leave

In-office catered lunches

Commuter stipend for Boston office

Qualifications

• 8+ years for Associate Director, 10+ years for Director in pharma/biotech.
• 5 years of regulatory experience required.
• Experience with IND/CTA submissions for clinical trials.

Responsibilities

• Develop and implement regulatory strategies for oncology and hematology.
• Oversee regulatory applications and agency communications.
• Manage submissions coordinating with regulatory operations.

Skills

Regulatory strategy

Drug development processes

Communication

Organizational skills

Interpersonal skills

Education

PharmD/MS or Bachelor's degree in life science

Job 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.

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:

The Assoc Dir/Director, Regulatory Affairs will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development of Kura’s oncology and hematology portfolio. The individual must possess excellent judgment, organizational and planning skills along with exceptional written and verbal communications.

To succeed, the candidate will have a sustained reputation for a values-driven, collaborative, engagement style where integrity and the consideration of our Patients drives decisions and actions.

• Contribute to the development and implementation of regulatory strategies for assigned projects.
• Lead and oversee the preparation, submission, approval, and maintenance of regulatory applications (e.g., IND/CTA, NDA/MAA, designation requests, pediatric study plans, etc.). Lead and/or assist in authoring regulatory documents and developing responses to Agency queries; manage submissions in coordination with regulatory operations.
• Lead and/or assist in the management of regulatory agency communications and interactions, preparation of briefing materials, coordination of rehearsals and minutes.
• Advise cross-functional development teams on regulatory requirements for development and approval pathways, including potential expedited pathways.
• Advise cross-functional teams and line management on regulatory risks, considerations, and strategies for program(s).
• Ensure activities and regulatory submissions are compliant with relevant laws, regulations, and guidances.
• Provides strategic and technical regulatory input for key product development documents.
• Perform regulatory research and intelligence to continually inform project teams of the evolving regulatory landscape and to identify changes and potential strategic implications.

JOB SPECIFICATIONS:

• Minimum 8+ for Associate Director, and 10+ years pharmaceutical/biotechnology industry experience, 5 plus years of regulatory experience
• PharmD/MS preferred, or Bachelors degree in life science
• Experience supporting NDAs and working on post-approval products, drug labeling experience would be great
• Experience leading IND/CTA submissions for clinical trials
• Excellent written and spoken communication skills
• Strong organizational skills
• Strong interpersonal skills
• Solid working knowledge of drug development process
• Experience with planning and managing IND/CTA submissions.
• Experience working and interacting directly with FDA and/or other agencies
• Good understanding of US and EU regulatory landscape
• Hematology/Oncology or orphan-drug experience are preferred
• Demonstrated ability to think critically and analyze scientific information while paying close attention to detail
• The ability to influence and negotiate professionally at various levels within the project team and with external partners

The base range for this role at the Associate Director level is $172,521 - $202,540 and Director level is $216,799 - $249,862 per year. 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

• 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 ofNovember 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 onX andLinkedIn .

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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