Director, Formulation

San Diego, CA

About Kura Oncology

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.

Director, Formulation

We are currently seeking a Director, Formulation to join our experienced drug development team in San Diego. This person will serve as the subject matter expert and lead the formulation/manufacture process development function, mostly through external CMOs. A strong team player who enjoys oncology drug development and has the ability to communicate and collaborate in an interdisciplinary environment is essential.

Essential Job Functions:

  • Direct Drug product development activities from lead optimization to clinical development and through commercialization, applying direct experience and knowledge in preformulation, formulation development, and process selection and scale up based on Quality by Design (QbD) approaches while providing oversight of GMP drug product manufacturing.
  • Represent the drug product development function in team meetings and sub-team meetings with Clinical Pharmacology, Clinical Development and Operations, Quality Assurance, Drug Substance and Analytical R&D and Stability, and Regulatory Affairs.
  • Design and conduct pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing activities on drug development programs.
  • Define and develop appropriate primary packaging for the finished drug product as needed.
  • Guide external third parties through technology transfer, process development, optimization, process qualification and validation activities related to DP manufacturing operations.
  • Oversee and manage contract manufacture organizations (CMO) to prepare manufacturing batch records, product development reports and other development-related documents. Be on-site, as necessary.
  • Act as drug product subject matter expert for ideation and drafting global regulatory CMC submissions (INDs, IMPDs, NDAs, MAAs). Author and review Drug Product CMC sections for regulatory filings.

Job Requirements:

  • Ph.D. or equivalent in pharmaceutical sciences or related field.
  • 10+ years of relevant industry experience in formulation/process development.
  • In depth knowledge and hands on experience on formulation and process development of small molecule oral an injectable dosage forms.
  • Manufacturing experience is strongly preferred.
  • Late-stage development and commercialization experience is a plus.
  • Thorough understanding of cGMP compliance and ICH guidelines.
  • Demonstrated experience with managing outsourced projects with contractors.
  • Strong leadership and collaboration skills.
  • Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment.
  • Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.

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
  • 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 has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor that recently received Breakthrough Therapy Designation (BTD) for the treatment of patients with certain head and neck cancers that carry HRAS mutations. Tipifarnib will also be evaluated in combination with an inhibitor of PI3Kalpha to treat between 20-50% of patients with HNSCC, the 7th largest cancer worldwide. KO-539 is an inhibitor of the menin/MLL interaction, which is are critically important for survival, growth, and proliferation leukemic blasts. Kura recently presented preliminary clinical data for KO-539 at the 2020 American Society of Hematology (ASH) meeting that demonstrated that it demonstrates favorable safety and tolerability and compelling evidence of activity in genetically defined AML patients.

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.