Director, Regulatory CMC

Boston, MA or San Diego, CA

Are you ready to join a team committed to making a meaningful impact through precision medicine? By joining Kura, 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 hold precision medicine to a high standard, applying cutting-edge science to create a more personalized approach in the treatment of cancer. We’ve changed the paradigm and improved the science of cancer treatment. We strive to cultivate a diverse and talented professional culture driven to develop therapies and solutions that are as unique as all of us.

As we continue to build a leading biotech organization with a strong culture, relentless execution, and a patient-focused mindset, Kura is planning to grow another 25% this year. To that end, we’re looking for our next innovator to join and help make our vision a reality. To take smart risks in pursuing novel areas of drug research and development and have fun along the way.

To succeed at Kura, you need to have a demonstrated reputation for putting the patient first and foremost, 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:

Reporting to the Senior Vice President, Regulatory Affairs the Director, Regulatory CMC will be responsible for providing regulatory CMC-related product development strategy and direction to the CMC,  clinical, non-clinical, and quality teams.  The Reg-CMC leader will be responsible for ensuring that the regulatory strategy is aligned with global regulatory agency(ies) requirements and expectations for development at varying preclinical to commercial phases are met with high quality.

  • Serve as the primary Regulatory-CMC representative and leader on project teams and committees, including leading meetings with regulatory agencies for all CMC-related matters (i.e., briefing document development, slide development, meeting coordination, team preparedness, and response).
  • Provide strategic CMC regulatory guidance for global development and registration programs (i.e., IND, CTA, NDA, MAA), working closely within the CMC teams to plan, integrate and align global expectations for development and commercialization. Define strategies to mitigate risks.
  • Manage timelines & lead the compilation, review, and approval process of CMC documents intended for regulatory submission. Manage CMC submissions, including writing, QC, and formatting of appropriate sections of IND/IMPD and marketing application sections, including responses to regulatory agency requests for information, working collaboratively with subject matter experts in CMC tech ops, QA, global supply chain, and other functions, as needed to ensure alignment of submission components.
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable global regulations and guidelines.
  • Manage and ensure compliance with all CMC reporting requirements, including management of the CMC change control process, tracking of global regulatory commitments, annual reports.
  • Manage consultants, contract staff, and vendors, as needed to support regulatory activities.
  • Keep abreast of new FDA / EMA regulatory requirements, as well as those from other key International regulatory authorities.
  • Act as the principal CMC, RA liaison with the FDA for original product approvals, maintenance, and negotiations.

JOB SPECIFICATIONS:

  • MS or BS degree with 5+ years of direct regulatory-CMC experience or combination of regulatory general/clinical and 3+ years of regulatory-CMC with demonstrated leadership skills.
  • Experience leading and driving successful regulatory submissions, with first-hand knowledge of and experience interacting with FDA CMC regulatory teams.
  • Deep understanding and demonstrated knowledge of eCTD elements and structure, including regulatory writing skills.
  • Strong experience and knowledge of US regulations and ICH guidance related to Quality, principles, concepts, industry practices, and standards.
  • Successful history working collaboratively across departments and levels.
  • Strong attention to detail with ability to understand the broader picture and priorities.
  • Effective working individually and aligning within a multi-disciplinary team, as well as with external partners and vendors.
  • Must be a dedicated self-starter with a high energy level and able to achieve results.
  • Must have strong communication and leadership skills-the ability to influence and work successfully with colleagues, customers, and corporate partners.
  • The candidate should have experience in handling multiple projects at a time.
  • Some travel may be required when appropriate.

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
  • 14 Holidays + 3 Floater Holidays (Including Winter Break), Summer Hours
  • 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
  • Cell Phone and Wellness 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 discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company’s diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology was founded in 2014 and has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor currently being evaluated in patients with certain head and neck cancers that carry HRAS mutations. KO-539 is an oral investigational drug candidate we are developing for the treatment of genetically defined AML patients with high unmet needs, currently in a Phase 1/2A clinical trial. KO-539 blocks the interaction of two proteins called menin and MLL that, together, are critically important for survival, growth, and proliferation of certain kinds of leukemia cells.

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. To apply, please submit your resume to careers@kuraoncology.com